| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CDRH: Fixed Form 3500A Section F13 Date Format |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- CDRH: Updates to 3500A form
- Retired/Removed Field "Form Code" from Section "Report Number".
- Added new field A3b (Gender).
- Modified field D4 (Additional UDI Numbers).
- Added new field F3-5 (Establishment Name).
- Modified field H9 to accept 50 chars.
- Repurposed new field H10 (Related Report Numbers).
- Renamed H10 to H11 (Additional Mfr Narrative).
- Refreshed eSubmitter AE Codes with 2023-24 IMDRF Codes.
- Clarified Header/Hint for Section H1.
- Modified Section H3.
|
|---|
| Fixes | CDRH: 3500A form - Resolved bugs in PDF generated. |
|---|
| Enhancements | CTP: Tobacco Product Ingredients Listing v2.9: Fixed the "State" dropdown displaying as disabled for the Importer and Manufacturer of Imported Products. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | 1. CTP: Transmittal v2.3 template - PRA text and OMB expiration date updates to Submission content: OM, SE, AS, EX, PM and PX.
2. CTP: Tobacco Health Document/Requested Document Submission v1.1 - PRA/OMB text update.
3. CTP: Tobacco Product Ingredient Listing v2.9 - PRA/OMB text update.
4. CTP: Tobacco 904(A)(3)(HPHC) template v1.8 - Text update. |
|---|
| Fixes | None |
|---|
| Enhancements | CTP: Updated CTP Transmittal Form v2.3 template. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CTP: Updated CTP Transmittal Form V2.3 template. |
|---|
| Fixes | None |
|---|
| Enhancements | 1. CDRH: Updated internal device code data stores.
2. CTP: Updated Tobacco 904(A)(3) (HPHC) Template for OMB expiration date. |
|---|
| Fixes | None |
|---|
| Enhancements | 1. CDRH: MDR - HECC and DPC are mandatory for INITIAL reports
2. CDRH: MDR - Suggestion that Contact Office Email is mandatory.
3. CDRH: MDR - IMDRF AE Codes Yearly Maintenance.
4. CDRH: MDR - Suggestion that Implanted Date is less than equal to Explanted Date.
5. CTP: Updated Tobacco Product Ingredient Listing form (TI), 904(A)(3) (HPHC), and Health Document/Requested Document Submission (HD) templates for OMB expiration dates.
6. CTP: The CTP Transmittal Form has been updated to replace 'Grandfathered' as a selectable submission type with the new 'Pre-Existing Tobacco Product' option. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | 1. CDRH: MDR - Increased ALL phone extension fields to accept 5 digits.
2. CDRH: MDR - Increased the length of "Establishment Name" under "G1 Continued" from 50 to 60 chars.
3. CDRH: MDR - Improved D2 product code filter to perform partial search.
4. CDRH: MDR - E3 value: Removed “If Other, please specify” option.
5. CDRH: MDR - Increased the field "Exemption Number" to accept 10 chars. |
|---|
| Fixes | CDRH: Fixed validation in H1 for report type supplements. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Removed IVD Turbo 510(k) template. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | 1. CDRH: Updated internal device code data stores.
2. CDRH: Updated IVD Turbo 510(k) template. |
|---|
| Fixes | None |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed internal device code data stores issue with auto update. |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed internal device code data stores issue with auto update. |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed internal device code data stores issue. |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed internal device code data stores issue. |
|---|
| Enhancements | CDRH: Updated internal device code data stores.
CDRH: Updated template for Report of Assembly of a Diagnostic X-Ray System. |
|---|
| Fixes | None |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed internal device code data stores issue. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | 1. CDRH: Updated internal device code data stores.
2. CDRH: Removed Non-In Vitro Diagnostic Device-510(k) template. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | CDRH: Updated MDR data stores to update the NCI (Concept) code value for FDA_CODE 3190.
CDRH: Updated MDR template with a minor text change. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: MedWatch Form 3500A-E3 option (305-Patient/Consumer) removed as it is a retired code. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CDRH: Fixed -GENC Country Code list issue to Radiation Emitting Product submission.
CDRH: Removed versions 2.4,2.5,2.5.2 for Radiation Emitting Product submission. |
|---|
| Enhancements | CDRH: Updated Internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CBER: ICSR submission modified to implement GENC county code standards. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | None |
|---|
| Fixes | CDRH: Fixed Health Effect - Impact Code list issue for MedWatch form 3500A submission. |
|---|
| Enhancements | CDRH: Updated internal device code data stores.
CDRH: Updated MedWatch Form 3500A submission.
CTP: Updated HD/RD Master Template to add a new header that contains informational text for users who are looking to submit PMTA information. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | CDRH: Fix to save the encoded attachment files details in the XML. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| | |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: emdr Form 510K submission issue. |
|---|
| Fixes | None. |
|---|
| Enhancements | CBER-CVAERS: Updated the ICSR.xml and related java changes |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | ALL: ZIP archives previously unable to be opened in Window's default ZIP software. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | - ALL: Added support for GENC-3 country code format for submissions supporting the GENC-3 standard.
- CDRH: Updated internal device code data stores.
- CDRH: MedWatch Form 3500A submission modified to implement GENC-3 country code standards.
- CDRH: Radiation Emitting Product submission modified to implement GENC-3 country code standards.
- CDRH: 806 Corrections and Removals submission modified to implement GENC-3 country code standards.
- CDRH: Report of Assembly of a Diagnostic X-Ray System submission modified to implement GENC-3 country code standards.
|
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- CTP:
Tobacco Harmful and Potentially Harmful Constituents Submission - Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
CTP Transmittal Form - Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
Listing of Ingredients in Tobacco Products - Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
Tobacco Health Document / Requested Document Submission - Updated business rules to load new versions of HD (V10) and RD (v1.1) sub templates
- Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
- Health Glossary updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
|
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | CTP: Updated outdated guidance document link in the Overview node of the following templates: - HDRD Master
(HEALTH_REQUESTED_DOCS_MASTER.XML) - HPHC Form (TOB 904(A)(3) TEMPLATE_V8.xml)
- TI Form (TOBACCO_INTRO_904_V13.xml)
|
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | CTP: Tobacco Health/Requested Document Submission: Corrected address information on the overview screen. |
|---|
| Enhancements | CTP: Tobacco Health/Requested Document Submission is a new master template available to users to submit a Health Documents (HD) submission or Requested Documents (RD) submission. The correct sub-template (HD or RD) will generate based on data collected from the user. - Tobacco Health Document Submission Enhancements
- Users will no longer use the CTP: Health Documents Form to create a Health Document submission. The CTP: Tobacco Health/Requested Document Submission template must be used instead.
- Removed metadata entry on the ‘Tobacco Health Documents’ screen. A new excel spreadsheet template is now available for download where users can enter their document file names and related metadata and attached.
- Tobacco Requested Document Submission Enhancements
- Users will no longer use the CTP: Transmittal Form to create a Requested Document submission. The CTP: Tobacco Health/Requested Document Submission template must be used instead
- An excel spreadsheet template is now available for download where users can enter their document file names and related metadata and attached.
|
|---|
| Fixes | CTP: Earlier versions of HD template and RD template (via CTP: Transmittal Form) will no longer be accepted, and the user will be required to use this new master template to submit an HD or RD submission. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | ALL: Fixed import/export issues related to address book. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- CTP:
- CTP Transmittal Form v2.0: Removed “SW” from the dropdown list of submission types
- CTP Transmittal Form v1.9: Updated allowed creation date and submission date. Last Create Date set to 03/04/2019, and Last Submit Date set to 09/05/2019
|
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CTP:
- Health Document Submission: In the 'Country' dropdown field, on U.S. Agent Screen, 'United States' is the only available option. 'State, Province or Territory' is now deleted.
- Product Ingredient Listing: In the 'Country' dropdown field, on U.S. Agent Screen, 'United States' is the only available option. 'State, Province or Territory' is now deleted.
- CDRH: Updated internal device code data stores.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CTP:
- Updated Tobacco Health Document Submission Template
- Updated Tobacco Product Ingredient Listing Template
- Updated Listing of Ingredients Import Spreadsheets
- CDRH: Updated internal device code data stores.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CTP:Updated Submittal Form Template
- CTP:Updated Ingredients Specification Import Spreadsheets
- CDRH: Updated internal device code data stores.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CTP:Updated HD Template to Match Paper Form:
- Updated Contact Information sections/fields
- Added two new fields in Health Documents section "Presence of document in the University of California San Francisco Tobacco Truth Documents Library database" and "Document Type."
- CDRH: Initial release of Quik Review Pilot.
- CDRH: Updated internal device code data stores.
|
|---|
| Fixes | CTP: HC Template – fixed minor issue with XML Property error. |
|---|
| Enhancements | CDRH: Updated internal device code data stores |
|---|
| Fixes | None. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- CDRH - MedWatch 3500A:
- Decommission of ICSR R1
- New 3500A template, version 2.2, includes the removal of all R1 specific fields
- Update to existing outosb.jar file to accommodate for changes to template
- Update to Medical Device Reporting codes
- Device Problem Codes
- Results Codes
- Method Codes
- Conclusion Codes
- CTP - TI Template Updates:
-
- Updated Instruction Text in the "Data Entry Method" section for "Product and Ingredient Listing" Options A and C
- Updated "Import_904_Ingredients Specification Update" spreadsheet to version v3a when Submission Type = A, B, C, F and "Products and Ingredients Listing" = B
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- Updated CDRH 510K and De Novo templates.
|
|---|
| Fixes | ALL: Update to auto-updater to resolve proxy support errors. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- Updated CDRH 510K and De Novo templates.
|
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CTP: Fix to TI template and import spreadsheet. |
|---|
| Enhancements | - CTP: Added an FDA created spreadsheet, for Leaf-Wrapped Cigar products.
- CDRH: Updated Radiological Health templates to display the 36 form burdens from 2017 in support of mandatory information collection reviewed by the Office of Management and Budget (OMB).
|
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CTP: Updated the E-Liquid spreadsheet to the .xlsx format ignore warnings that describe possible file type conversion. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- CDRH: Report of Assembly of a Diagnostic X-Ray System template updated:
- Updated expiration date on the Introduction Page (text change)
- Updated Document Mail Center Room # on the Introduction Page (text change)
- CTP: Updated TI template and spreadsheets:
- Added method for users to submit their own spreadsheets
- Updated FDA-created spreadsheets section to include a spreadsheet specifically for e-liquid products and a spreadsheet for any product type
- Updated Product Listing and Ingredient Listing information sections to dynamically change the text displayed based on the data input selected
|
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CTP: Removed watermarks from the FDA-created product spreadsheet and removed "E-Liquids only" from the description. |
|---|
| Enhancements | - CDRH: Updated internal device code data stores.
- Updated documentation, including: Quick Guide, Digital Signature Guide, and FAQ
|
|---|
| Fixes | Address questions incorrectly default to "US" even if no data entered in address fields. |
|---|
| Enhancements | - ALL: Increased the memory limit within "File" > "Preferences" menu, the upper limit is now 5GB.
- CDRH: Updated internal device code data stores.
- CTP: Multiple updates to templates and additional data import spreadsheet:
- Added question to ask users for the method used for entering product, component, and ingredient information.
- Modified instructional and informative text based on method of entry.
- Added a spreadsheet for importing e-liquid product information.
|
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. CTP: Multiple updates to templates and additional data import spreadsheet:
Added question to ask users for the method used for entering product, component, and ingredient information. Modified instructional and informative text based on method of entry. Added a spreadsheet for importing e-liquid product information |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Updated internal device code data stores. |
|---|
| Fixes | None. |
|---|
| Enhancements | 1. CTP: Updated submission templates to allow Excel (XLSX) file attachments.
2. CDRH: Added the OMB number and expiration date to the submission type description on the "Create New Submission" dialog. |
|---|
| Fixes | CTP: To maintain consistency with the eSubmitter application, the “Co-Package” question on the Import spreadsheet has been marked as required. |
|---|
| Enhancements | None. |
|---|
| Fixes | CTP: Updated TI template to correct maximum file size of submission batch files. |
|---|
| Enhancements | None. |
|---|
| Fixes | CTP: Updated TI template to allow for letters and numbers for the FDA-Assigned Tracking Number (TP Number) |
|---|
| Enhancements | - CDRH: Removed "NI" (No Information) radio button from Section H of MedWatch 3500A.
- CDRH: Updated the form expiration date of (806) Corrections and Removals.
- CTP:
- Enhanced CTP templates to provide ability to attach .csv and .txt files
- Enabled file validation in CTP templates to show error message when files with unsupported characters are attached
|
|---|
| Fixes | None. |
|---|
| Enhancements | ONADE: The Blood Level Bioequivalence Protocol QbR template Pilot has been completed, the template has been updated to reflect comments received during the Pilot period. |
|---|
| Fixes | - ONADE: Removed the "Are you submitting a labeling supplement that qualifies for a 60 day review (21 CFR 514.8(c)(2)(I)(A) or (D)?" question from A-C/R-NF submission types since it is not applicable for an ANADA application.
- ONADE: Fixed an issue where the Purpose of Submission was not being generated for A-B-AR submission types.
|
|---|
| Enhancements | CDRH: Updated product code, guidance, and standards lookup tables. |
|---|
| Fixes | None. |
|---|
| Enhancements | CTP: Template enhancements including: -
- Require 'parent' TI STN for option "f" in Submission Type selection
- Accept additional file extensions, specifically .csv and .txt
- Turn on 'file validation' to display error for unsupported characters in file names
|
|---|
| Fixes | CTP: Following issues have been fixed: -
- Leaf Tobacco option missing from the Dropdown for option "f" in Submission Type selection.
- State/Province fix for Authorized Representative outside United States
|
|---|
| Enhancements | None. |
|---|
| Fixes | CDRH: Fixed issue in generated contents of the MedWatch 3500A submission package. |
|---|
| Enhancements | - CVM OSC DERS: Initial release of CVM: OSC DER SUBMISSIONS templates, which include CVM post-market semi-annual, annual, and special Drug Experience Reports (DERs) submission types. These submissions are submitted to the Office of Surveillance and Compliance (OSC).
- CVM OSC DERS: Updated the Quick Guide to list the availability of post-market OSC DER submission types and provide digital signature instructions related to these submissions.
- CVM OSC DERS: Updated the User Manual to provide digital signature instructions related to OSC DER submissions.
- CDRH: Updated fields on screen Consignee(s) Information and associated spreadsheet for importing consignee data.
- CDRH: Added new fields and business rules to the MedWatch 3500A form. Additions include:
- New section C for Suspect Products
- New Race and Ethnicity fields in Section A
- Updated field description in Section D11
- Enabled Pre-1938 and OTC Product Checkbox in Section G5
- Enabled Adverse Events Term Section G8
- Section D11 increase in characters allowed, now accommodates 500 characters
- Added business rules validation for new sections and fields
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CVM ONADE: Added support for multiple file attachments within the 3.0 Claim of Categorical Exclusion section of the Environmental P/NV template.
- CVM ONADE: Added support for linking documents within G-OT submissions.
- CVM ONADE: Added an explanatory message, as well as support for collecting Degree information within the US Agent, Responsible official, and Submitter contact Information.
- CVM ONADE: Added support for collecting additional Early Information details within I-H-SP submissions.
|
|---|
| Fixes | - CVM ONADE: Fixed an issue where original submissions for all document types were not properly displaying when no currently established file or application was provided.
- CVM ONADE: Removed a duplicate required question from the product description screen of the N-E-OT submission type.
|
|---|
| Enhancements | None. |
|---|
| Fixes | ALL: Fixed handling of tabular data relationships. Relationships previously relied on correct sequencing of records within submission data files and could become corrupted if records became unsequenced. Handling of relationship data is improved and no longer has a dependency on record sequences. |
|---|
| Enhancements | CVM ONADE: Adjusted the Early Information (EI) message text within INAD submissions to better clarify the intent |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH eCopy: Standardized validations across eCopies template to align with validations performed by eCopies Loader and validator tool |
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CVM ONADE: Fixed an issue within the Original NADA submission type where the Amendment section was not being properly displayed. |
|---|
| Enhancements | None |
|---|
| Fixes | CVM ONADE: Fixed an issue within General Correspondence submission types where the Other; Unclassified (OT) section was not being displayed properly. |
|---|
| Enhancements | CDRH: To support the reorganization of districts into divisions the district dropdown was replaced with radio buttons for each division. |
|---|
| Fixes | None |
|---|
| Enhancements | CVM ONADE: Adjusted the Chemistry, Manufacturing and Controls (MC) section for INAD and JINAD Major Technical Section (P) submissions by refining the outline and question structure, while also fixing issues related to incorrectly identified missing data. |
|---|
| Fixes | - CVM ONADE: Added additional document types when submitting an Administrative Request (AD) to change the Responsible Official/U.S. Agent.
- CVM ONADE: Adjusted the foreign visitor status question to be hidden within the Firm Participants screen when no foreign visitors have been designated to be included to avoid potential confusion when the response is blank within the report output.
|
|---|
| Enhancements | CDRH: Added character validation to limit characters allowed in file names. |
|---|
| Fixes | CDRH: Address text updated throughout template. Text "G0609" updated to "G609" |
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fixed an issue within the General Correspondence/Request for Meeting submission type where the meeting information section was not being displayed properly. |
|---|
| Enhancements | All: Replaced the "Address Book" and "Contact Book" with a new consolidated address book. The consolidated address book provides the following features: -
- Existing address book entries and contact book entries have been moved to the consolidated address book.
- One location for managing establishments/organizations and contacts.
- Contacts are maintained under affiliated establishments/organizations.
- An Organization/Contact view for managing contacts affiliated with each organization.
- A Contact only view for managing and selecting individual contacts.
|
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fixed an issue within the General Correspondence/Final Printed Labeling submission type where the Final Printed Labeling section was not being displayed properly. |
|---|
| Enhancements | - CVM: Fixed a typo within the 3.0 Claim of Categorical Exclusion section of the Environmental P/NV template.
- CVM: Increased the response length of the Protocol Title question from 250 to 500 characters within the Bioequivalence Protocol E/BQ template.
- CVM: Added ability to submit Administrative Requests (AD) as a Supplement (C) to an ANADA/NADA.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CVM: Updated the OMB number expiration dates within the Document Information sections.
- CVM: Added eXtensible Markup Language(XML) and SAS XPORT (XPT) file attachment support to questions within P/NV, X/CE, and X/EA templates.
|
|---|
| Fixes | CTP: Tobacco Product Ingredient Listing – Resolved display of incorrect component type options following import of products from spreadsheet. |
|---|
| Enhancements | None. |
|---|
| Fixes | CBER eVAERS: Corrected the country code standards used for reporter information to use ISO 3166-1. |
|---|
| Enhancements | - CBER eVAERS: Adjusted the minimum acceptance criteria for the Patient's Date of Birth question to year and month.
- CVM: P/NV templates:
- Modified the wording of the categorical exclusion citations on Screen 3.0 to reflect the wording in the regulations.
- Modified or added instructions on Screen 3.0 for clarity.
- Consolidated sub-screens 3.1 through 3.7 into Screen 3.0.
- Consolidated screens 4.0 and 4.1 and screens 5.0 and 5.1, and removed unnecessary questions on these screens.
- Modified the wording of the questions on Screen 1.1, Reference Listed New Animal Drug.
- CVM: J/X/CE templates: added Screen 1.1, Reference Listed New Animal Drug.
- CVM: I/X/EA template: removed unnecessary questions on Screen 3.0.
|
|---|
| Fixes | None. |
|---|
| Enhancements | CVM ONADE: Adjusted the designation status question text and hint within product description screens to include minor use/minor species (MUMS) text for improved clarity. |
|---|
| Fixes | CTP: Corrected discrepancy between Tobacco Product Ingredient Listing template and import spreadsheets for "Quality – Unit of Measure" field. |
|---|
| Enhancements | 1. CTP: Tobacco Product Ingredient Listing – Released a new version of the TI template (v2.0) to allow for data entry of newly deemed products as well as their component, ingredient, and identical product information. This version also contains updates to the Submission Type, Identification Information, and Confirmation screens to comply with the updated paper form (FDA 3742).
2. CVM ONADE: JINAD Blood level bioequivalence protocol (E) template updated to question-based format.
3. CVM ONADE: Added support for identifying foreign attendee participation within meeting requests (Z). |
|---|
| Fixes | CVM ONADE: Corrected label identifier references for Veterinary Feed Directive (VFD) within associated templates. |
|---|
| Enhancements | CVM: Amendment template now supports the functionality of allowing a sponsor to change the responsible official. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Release of new template 806 Corrections and Removal Reporting to support reporting of medical device corrections and removals to the Center for Devices and Radiological Health (CDRH) as outlined by 21 CFR 806 |
|---|
| Fixes | CDRH: Corrected spelling errors in template text. |
|---|
| Enhancements | None. |
|---|
| Fixes | CBER eVAERS: Fixed an issue where Reaction(s)/Event(s) resulting in death prevented submission packaging. |
|---|
| Enhancements | CVM: Patent Question Modified in the following Templates : NADA A-OT, E-OT, C-B1 and R-B1. |
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CBER eVAERS: Fixed an issue where structured medical history was required when none may be available. |
|---|
| Enhancements | CBER eVAERS: Various template and output message changes: -
- Reaction(s)/Event(s) section changes (i.e., new Caused/Prolonged Hospitalization rules).
- Drug Information section changes (i.e., the first product listed in the drug information section must be a vaccine and characterized as Suspect or interacting).
- Drug/Dosage section changes (i.e., moving the collection of the regional vaccination facility and associated healthcare professional to a separate section).
- Patient Demographics and Characteristics section changes (i.e., added "NI" null flavor to patient ethnicity).
- Relevant Medical History Patient and Parent section changes (i.e., allowing support for both structured and unstructured data).
- Application Number for non-vaccine products to be reported with NDA/ANDA prefix when available for US reports.
|
|---|
| Fixes | - CBER eVAERS: Fixed an issue within the output of the Parent Route of Administration section of the Drug Dosage information.
- CDRH: The Rad Health laser product report template was updated in several sections of the Technical Data tab to remove an improper "Required" status of some questions and to modify a couple of other questions to permit text entry rather than just numeric entry.
|
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fixed an issue where users were unable to attach Package Insert "other labeling" when using the A-E-OT eSubmitter template. |
|---|
| Enhancements | - CVM: All OSC DAF templates that have a Species Class node will now have the use level listed by class, not just species. Different classes within a species can now have different use levels.
- CVM: eSubmitter amendment templates no longer contain the selection of End Review Amendment for the following submission types:
- CVM: Minor textual change were made in the following templates:
- NADA-A-OT: Nodes 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7
- NADA-C-B1: Nodes 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7
- ANADA-A-OT: 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9
- ANADA-C-B1: 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8
- CTP: All Templates - Added informational message for users to ensure they are using the most recent version of eSubmitter and not blocking automatic eSubmitter updates. Also added information to the packaging screens to introduce the new CTP Portal.
- CTP: ESG Transmittal Form - Changed the name of the template to CTP: Transmittal Form.
- CDRH: eCopy - Included additional invalid character support checks for file names.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CVM: Released new template to enable the animal drug industry to voluntarily submit submissions to a Minor species Index File System (MIFS) electronically. Production Deployment July 1st, 2016.
- CDRH: Deactivated the ISO-13485 template on 7/1/2016 from production since the program ended and the grace period has expired.
- CDRH: Updated the Medical Device eCopy template to include an introductory page with guidance information on the program.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CBER VAERS: Changed the drug application number to only support a BLA number.
- CBER VAERS: Changed all occurrences of MPID to require NDC formatted data entry when provided for US reports.
- CBER VAERS: Changed the output message for phone, fax, and email to include an additional telecommunications type when a null flavor is provided.
|
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CDRH: Fixed an issue within the PDF MedWatch report output where the narrative text in section H10 was not being included. |
|---|
| Enhancements | - CVM: Implementation of established name change along with HFV-180 division change.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | None. |
|---|
| Enhancements | - CBER VAERS: Changed the form title to better reflect that only eVAERS submissions are currently supported.
- CBER VAERS: Changed the email support links to reference the CBER ICSR Submissions help desk.
- CBER VAERS: Adjusted the Patient State to support null flavor for US reports.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | None. |
|---|
| Enhancements | CVM: Implementation of the B1 Generic question for MCSR in ANADA submissions. |
|---|
| Fixes | None. |
|---|
| Enhancements | None. |
|---|
| Fixes | CBER VAERS: Fixed an issue related to a few international country codes not being converted correctly within the output message. |
|---|
| Enhancements | CDRH: Updated product code, guidance, and standards lookup tables. |
|---|
| Fixes | - All: Fixed an issue where the re-ordering of rows within tabular screens could result in concatenated information.
- All: Fixed an issue where a Manifest creation error was resulting for some users due to rights issues related to where the Manifest file was being created.
- All: Fixed an issue where the Trade Mark symbol could no longer be included within textual responses.
- CVM: Fixed an issue where the report output did not always include all screen sections for a specific submission type.
|
|---|
| Enhancements | CDRH: Updated product code, guidance, and standards lookup tables. |
|---|
| Fixes | None. |
|---|
| Enhancements | - All: Updated the country list.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | CBER VAERS: Fixed an issue where improperly structured MPID data was allowed during data entry that would not pass validation when received at FDA. |
|---|
| Enhancements | CDRH: Updated product code, guidance, and standards lookup tables. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CVM OSC DAF: Questions removed from IFA Notice of Shipment template.
- CVM OSC DAF: Section added to and wording for questions changed for IFA Firm's Slaughter Notice template nodes 3.0 - 3.3.
- CVM OSC DAF: Confirmation pop-up removed from Core Questions amendment question, and hint text modified for Document Information question.
- CVM OSC DAF: Text change for questions in IFA Notice of Shipment template screens 2.0 and 4.0.
- CVM OSC DAF: Hint text modified for Core Questions IFA submission Document Information question.
- CVM OSC DAF: Added hint to withdrawal period question on screen 5.0 for IFA Firm's Slaughter Notice template.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CVM ONADE: Chemistry Supplement Reactivation - Prior Approval template informational message text change.
- CVM ONADE: Users can now attach multiple VFD Statement Files when submitting Animal Feed Labeling.
- CVM ONADE: Chemistry, Manufacturing and Controls template Module 3 is now optional when "Feed Method Trial Study with Data Only" option is selected.
- CVM ONADE: Cross-node relationships have been added to nodes 2.3.S Drug Substance to 2.3.S.7 Stability to allow entry for multiple Active Ingredients on Chemistry, Manufacturing and Controls template.
- CBER VAERS: Adjusted the primary source rule requiring either a first or last name so that it only impacts US source reports.
- CBER VAERS: Adjusted the patient country to support MSK an NI null flavors when NOT a US report.
|
|---|
| Enhancements | CBER VAERS: Added the following three, more generic options, to the 'Vaccine Anatomical Approach Site' question: Arm, Thigh, and Buttock to support conditions when more specific Left or Right information is not available. |
|---|
| Fixes | None. |
|---|
| Enhancements | CBER VAERS: Added the null flavor options: UNK, ASKU, and NI to the 'Vaccine Anatomical Approach Site' question within the 'Vaccines Given Within Four Weeks' section. |
|---|
| Fixes | None. |
|---|
| Enhancements | - All: Added restrictions to the name of the submission file when created by the user to only allow English characters (A-Z, a-z), digits, underscores, dashes, and parenthesis.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER VAERS: Fixed rules regarding Patient Age and Reaction/Event Dates and Duration that were not correctly supporting null flavor values.
- CBER VAERS: Fixed response length and numeric type formatting across questions, as needed.
- CBER VAERS: Removed the TRICARE Beneficiary option and added null flavor support to the Patient's Military Status.
- CBER VAERS: Fixed an issue where the Email Address for the Healthcare Professional/Best Contact was not outputting in the generated message.
- CBER VAERS: Adjusted UCUM values (Trimester, Decade) to output in lowercase within the generated message.
- CBER VAERS: Fixed an issue where Treatment Facility responses were not properly disabled when switching to 'None of the Above' within Seriousness Criteria of the Event.
|
|---|
| Enhancements | - CBER VAERS: Adjusted the dosage effective time to require at least one of the response types (i.e., start time, end time, duration).
- CDRH: Added file path/name restrictions to Radiation Emitting Product submissions to limit the characters allowed to english alphanumeric characters, underscores, dashes, parenthesis, and spaces.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER VAERS: Adjusted the MSK null flavor rule for primary source reporters. The null flavor MSK within the primary source reporter section is only allowed for non-US reports based on the country address for the primary source reporter for regulatory purposes (ICH C.2.r.5). Initially, the rule was applied to all primary source reporters; however, per VAERS program requirements, MSK is only not allowed for US reports for the source associated with ICH C.2.r.5.
- CBER VAERS: Fixed an issue where free text only responses for dosage form, route of admin., and parent route of admin. were not being included within the generated output message.
|
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fixed an issue preventing completion and submission of an Original General Correspondence document. |
|---|
| Enhancements | - CVM: Templates added for Office of Surveillance and Compliance (OSC) Division of Animal Feeds (DAF):
- Food Additive Petition (FAP)
- Original FAP
- Reactivation of Original
- General Correspondence
- Protocol - No Data
- Protocol - Data
- Firm's Request for Changes to CVM's MOC
- Request for Meeting
- Investigational Food Additive (IFA)
- Initial IFA
- Notice of Shipment
- Amended Food Use Authorization
- Protocol - No Data
- Protocol - Data
- General Correspondence
- Original Food Use Authorization
- Data Submission
- Firm's Slaughter Notice
- Firm's Final Disposition
- Firm's Request for Changes to CVM's MOC
- Request for Meeting
- GRAS Notice
- Initial Submission
- General Correspondence
- Original Notification
- Firm's Request for Changes to CVM's MOC
- Request for Meeting
- CDRH: Removed the 510(k) pilot template as the pilot period has ended.
- CDRH: Added new items to the product code class filter to further delineate between class options.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | None |
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fixed an issue related to the submission report recieved by FDA |
|---|
| Enhancements | None. |
|---|
| Fixes | - CBER VAERS: Fixed an issue within the output message where an indication for use as reported by the primary source was provided in text form without a corresponding MedDRA code.
|
|---|
| Enhancements | None. |
|---|
| Fixes | CVM: Fix to (J)INAD Chemistry, Manufacturing and Controls template to: - Restore the functionality to enable nodes 2.3.S & 2.3.P when appropriate selections are made.
- Restore the functionality to disable all nodes between 1.0 and 5.0 when “Abbreviated Response” is selected on node 1.0.
|
|---|
| Enhancements | CDRH: Updated the eMDR lookup tables to remove inactive codes. |
|---|
| Fixes | None. |
|---|
| Enhancements | CDRH: Adjusted template to reflect latest eMDR changes. |
|---|
| Fixes | None. |
|---|
| Enhancements | - CVM: Chemistry, Manufacturing, and Controls template changes including:
- The list builder question remains disabled and not required after the user selects "No" as a response to "Are there any additional CVM Submission Numbers associated with your CVM Technical Section Incomplete Letter(s)?".
- The CMC Sections question is always required.
- CVM: Core Questions template changes including:
- HFV-100 added to the list of values for G submission types.
- CBER VAERS: Adjusted the business logic associated with patient age information. Age Group is now required entry when no other age related information is available. However, Age Group supports null-flavors (ASKU, MSK, NI, UNK) when absolutely no age related information is available.
- CBER VAERS: Patient and Soure Reporter County is automatically output as the null-flavor "NI" for non-US reports.
- CBER VAERS: Patient and Soure Reporter State/Province now includes the null-flavor option of "NI" for non-US reports.
- CBER VAERS: Parent sex is now required entry when a parent is included within a report.
|
|---|
| Fixes | CBER VAERS: Vaccination Facility Military Status has been corrected to now support "false" as an option for the output. |
|---|
| Enhancements | |
|---|
| Fixes | - CDRH: Fixed an issue with the patient and device problem code lists.
- CDRH: Fixed an issue where the "Other Number" response from section D was missing from the output file.
|
|---|
| Enhancements | - CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER VAERS: Adjusted the language codes to properly reflect the ISO 639-2 data standard.
|
|---|
| Enhancements | - CBER VAERS: Adjusted the limit for adding associated persons so that only one parent can be added for VAERS reporting.
- CBER VAERS: Adjusted the patient drug history section so that one drug history item is required, the name of the drug should be set to "NA" if no drug history information is available.
|
|---|
| Fixes | - Fixed an issue related to the table question losing data when a submission is reopened.
|
|---|
| Enhancements | - Released CBER Individual Case Safety Reports (ICSR) to Production.
|
|---|
| Fixes | - Fixed an issue where some users were incorrectly receiving validation errors resulting from valid phone entry.
|
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Fixed an issue in the I/P/NV eSubmitter template preventing sponsors from being able to submit when they are requesting a Categorical Exclusion.
- CVM: Fixed an issues in the N/B/CA and A/B/CA templates pertaining to missing questions.
|
|---|
| Enhancements | - Added support under preferences for identifying where contact/address book information is stored.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER VAERS Pilot: Removed the redundant folder from the output, now the output message will be saved directly to the package folder.
- CBER VAERS Pilot: Revised the Testing Result data entry section to better support singular and range values.
- CBER VAERS Pilot: Adjusted UCUM selection lists and numeric representations (integer/decimal), as needed.
- CBER VAERS Pilot: Added missing codes to the Facility Type list.
- CBER VAERS Pilot: Removed duplicates from the Language selection list.
- CBER VAERS Pilot: Refined the validation checks on the MedDRA version number to ensure proper formatting.
- CBER VAERS Pilot: Adjusted the Vaccination Military Status to support Yes, No, and No Information.
- CBER VAERS Pilot: Added Code System data entry to Dose Form, Route of Admin, and Parent Route of Admin when entering a term that is not part of the SPL code set.
- CBER VAERS Pilot: Fixed an issue where the Name of the Drug Provided was not properly outputting NA as a null flavor.
- CBER VAERS Pilot: Added a hint to MPID Version/Date entry to reflect the proper format of the data to be provided.
|
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Fixed an issue within the generated submission package where the purpose of submission was not set correctly for Z and Y Submission Types (A/Z/OM, A/Y/OM, G/Z/OM, G/Y/OM, I/Z/OM, I/Y/OM, J/Z/OM, J/Y/OM, N/Z/OM, N/Y/OM, V/Z/OM, V/Y/OM).
|
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Fixed an issue with the I/J-P-MC templates that was preventing access to Module 3 information.
- CDER/CBER GDUFA Generic Facility Self-Identification template: Fixed an issue related to Business Operations and non-generics.
|
|---|
| Enhancements | - CTP: Users will no longer have the ability to attach zip files in any of the submissions.
- CBER: Inactivated the Investigational New Drug (IND) Application, including Antivenin INDs, eCTD Structured template.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER VAERS Pilot: Fixed an issue where the drug application number was incorrectly being output when no user response was provided.
|
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Updated eSubmitter to create a new Submission Classification Code (OM-ONADE Meeting). Removed PS and OO as sub class codes. Added a radio button selection to all the Z templates to allow for the selection of either Pre-submission conference (PS) or ONADE Other (OO) meeting.
- CVM: Updated the INAD A-0000, INAD - Z, GC-A-0000 and GC-Z Templates to include questions pertaining to the submission of early information.
- CVM: Added a new team to all the meeting request (Z) templates: Team 4 Canine, Feline and Wildlife (HFV-118).
- CVM: Updated the (J)INAD templates to change the business rules to collect only one referenced submission.
- CVM: Updated the (J)INAD B-OT, J/INAD-P-NV, and J/INAD-X templates.
- CVM: Deactivated the VMF-P-OT Template.
- CVM: Updated (A)NADA R-CS, AS Templates to add a message instructing sponsors that might be trying to respond to a Prior Approval Supplement incomplete letter as a CBE30.
- CBER VAERS Pilot: Adjusted available nullflavor responses within Patient/Parent Race and Vaccination Facility Type.
- CBER VAERS Pilot: Adjusted the Dose number Unit to properly support "{DF}".
- CBER VAERS Pilot: Fixed an issue where the Primary Source was not outputting the County Code when identified as the Patient.
- CBER VAERS Pilot: Fixed an issue where the Vaccination Facility Military Status was not properly converting a "No" response to "NI" in the output.
- CBER VAERS Pilot: Adjusted the OID used when outputting the FDA Specialized Product Types.
- Fixed an issue where responses to tabular questions could not be deleted without adding a new response.
|
|---|
| Enhancements | - CBER: Added support for multiple codes of "Illness at Time of Vaccination" within the VAERS Pilot template.
|
|---|
| Fixes | - CDER/CBER: Fixed an issue with Generic Drug Facility Electronic Self-Identification submission type output related to international phone numbers.
|
|---|
| Enhancements | - CBER: Released an updated CBER VAERS template and output capability for VAERS Pilot Participants.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | |
|---|
| Enhancements | |
|---|
| Fixes | - Fixed an issues related to the CDRH 510(k) template and international phone/fax numbers preventing the output from generating.
|
|---|
| Enhancements | - CTP: Updated the Ingredient Listing, Health Documents, Harmful and Potentially Harmful Constituents and the ESG Transmittal Form to collect a cover letter in a separate attachment question. Updated question text on existing attachment question and separated the Comments section to stand alone. Added a message to inform users of the changes.
- Enhanced the HTML Submission Report output to include Expand/Collapse capabilities within section headers.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - Fixed a header formatting issue within the Adobe PDF version of the Submission Report.
|
|---|
| Enhancements | - CBER: Updated the eSubmitter Electronic Participant Checklist to reflect new DCC mailing address.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CTP: Fixed an issue within the HPHC template where 'Other' text for mexthod of separation and detection were not properly being saved.
- CDRH: Fixed an issue within the Report of Assembly of a Diagnostic X-Ray System submission so that a zip code extension is no longer required within the data entry.
|
|---|
| Enhancements | - CDRH 510(k): Adjusted the list of available file types that can be attached within a submission (e.g., removed support for Microsoft Word .docx files).
- CDRH 510(k): Adjusted text within the template and eSubmitter to reflect the end of the CDRH 510(k) pilot. Going forward, only applicants that have already submitted submissions can continue to submit documentation via this eSubmitter template.
|
|---|
| Fixes | |
|---|
| Enhancements | - CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | |
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Fixed an issue where eSubmitter submissions greater than 2 GB cause the ESS Mediator to "Hang" or become nonresponsive thus not processing the submission and making it available for review. Developed a viable solution to accommodate eSubmitter submissions that are up to 10 GB in size.
|
|---|
| Enhancements | - CBER: Added new approach to supporting Null Flavor capabilities within the ICSR template.
|
|---|
| Fixes | |
|---|
| Enhancements | |
|---|
| Fixes | - CVM: Fixed the issue preventing the activation of Node 5.0 in the INAD P-MC, JINAD P-MC, and ANADA A-OT templates.
|
|---|
| Enhancements | - CVM: Two modifications were made to both the I-P-NV and J-P-NV templates: 1) permit both PDF and XML files to be attached to Node 6.0 and 2) change the need for a file attachment from required to optional for Nodes 3.1, 3.3, 3.4, and 3.5.
- CBER: General updates to the ICSR template and HL7 output message.
|
|---|
| Fixes | |
|---|
| Enhancements | - CVM: Implemented 1 GB submission file size limit. All submissions greater than 1 GB will be broken into multiple files that are less than 1 GB in size. Each ZIP file must be submitted separately through the ESG to complete the submission. Once all submission "pieces" are received, one CVM ESS receipt will be issued.
- CVM: Allow the sponsor to attach the pharmaceutical development report as a PDF document in the following templates, J-P-MC, I-P-MC, A-A-OT.
- CVM: Added a hint to Section 2.3.P.4.d, on the Excipient Manufacturer Details tab in the following templates J-P-MC, I-P-MC, A-A-OT.
- CVM: Updated Chemistry Manufacturing and Controls technical section templates (I/P/MC and J/P/MC) and the A-A-OT template to permit identification of whether the sponsor is submitting a two phased submission.
- CVM: Deleted the question in Section 2.3.P.3.a, "What are the quality standards for each component used in the manufacturing process?" in the following templates, J-P-MC, I-P-MC, A-A-OT, A-E-OT.
|
|---|
| Fixes | - An issue within the FDA production webserver that prevented downloads of the previous eSubmitter updates has been resolved.
|
|---|
| Enhancements | - CDRH 510(k): Added a question in Patient Contact Materials that request color additive information. This question is necessary according to the RTA Guidance document.
- CDRH 510(k): Added ability to add Preamendment, Exempt, down-classified PMA, and De Novo submissions as predicates.
- CDRH 510(k): Removed listing of the predicates as Related Submissions, they will be obtained separately within the SE Comparison section.
- CDRH 510(k): The user may now choose to have the 510(k) Summary be produced automatically, using data entered throughout the template. The data used to produce the 510(k) Summary are clearly distinguished and advise in prominent text to not include confidential information in these sections, since the 510(k) Summary is made public if the submission is found SE.
|
|---|
| Fixes | - Fixed a report output and packaging issue involving international phone numbers.
|
|---|
| Enhancements | - CBER: General updates to the ICSR template and HL7 output message.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CDRH and CBER: Fixed an issue where dates earlier than 1950 were no longer supported (related to ICSR submission types).
|
|---|
| Enhancements | - CBER: Added support to enforce that Reaction/Event matrix items are always associated to an existing Drug and Reaction within the ICSR template and HL7 output message.
- CBER: Added support for partial dates within the ICSR template and HL7 output message.
- CBER: General updates to the ICSR template and HL7 output message.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | |
|---|
| Enhancements | - CBER: Updates to the ICSR template and HL7 output message.
- CDRH: Added the OMB control number to ISO13485 template, The OMB control number is 0910-0700 and expires February 28, 2015.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | |
|---|
| Enhancements | - CVM: An administrative indicator was added to the following templates to address the AGDUFA II modifications: ANADA Supplement (A/C/B1), NADA Supplement (N/C/B1), and ANADA Original (A/A/OT).
- CBER: Added product correspondence as a type of submission in Whole Blood and Blood Components submissions.
- CDRH: Added a rule to the CDRH 510K submission type to ensure Other Regulations cannot contain a Class III product code unless also designated within the Primary Regulation.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CBER: Fixed the font size issue with the Whole Blood and Blood Components PDF submission report output.
|
|---|
| Enhancements | |
|---|
| Fixes | - CVM: The following templates were rolled back to the last version to the 6/13/14 release: ANADA Supplement (A/C/NF) and NADA Supplement (N/C/NF), to remove the ADUFA III specific questions that will not be available until 10/1/14.
|
|---|
| Enhancements | - CBER: Released CBER Individual Case Safety Reports (ICSR) to Production for VAERS Pilot Participants.
- CBER: Updated the BLA submission mailing address and included an updated CBER eSubmitter Participant Checklist.
- CDRH: Updated product code, guidance, and standards lookup tables.
|
|---|
| Fixes | - CDRH: Fixed an issue where standards did not always properly maintain the selected organization and year references.
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| Enhancements | CVM: In reauthorizing the Animal Generic Drug User Fee Act of 2013 and the Animal Drug User Fee Act of 2013, the FDA committed to provide enhancements to its review environment that include substantive changes to the Center for Veterinary Medicine's (CVM) Submission and Review System. The enhancements that were agreed to in this reauthorization are outlined in the Goals Letter. This release will update the following templates for the Office of New Animal Drug Evaluation (ONADE). Templates impacted by modifications for AGDUFA II: - A-E-OT, A-C-CS, J-P-BQ, J-P-HF, J-P-MC, J-P-NV, J-P-PE
Templates impacted by modifications for ADUFA III: - A-C-AS, A-C-B1, N-A-OT, N-C-B1, N-C-CS
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| Fixes | |
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| Enhancements | - CTP: Adjusted the CTP Document Control Center mailing address within the packaging dialog to reflect the new address for mailing CD submissions.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CDRH: Fixed an issue within the MedWatch submission output that didn't properly differentiate between the manufacturer contact and site (i.e., G1 and G2) when site information was available but no contact information was provided.
- CDRH: Fixed an issue within eCopies to remove certain special characters (e.g., pound, tilde, single quote) from file names before generating the submission output.
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| Enhancements | - CDRH: Released new electronic Premarket Notification 510(k) Pilot template.
- CDRH: Adjusted the eCopies template to use a simpler file attachment approach.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CVM: Fixed an issue where international phone numbers were formatted incorrectly within the HTML report output.
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| Enhancements | |
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| Fixes | - CVM: Fixed an issue where data was lost when updating the Document Number.
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| Enhancements | - CDRH: Updated the OMB form expiration date to January 31, 2017.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CTP: Fixed an issue where numbers being imported from a spreadsheet within a tabular node were failing to import properly due to extra spaces appearing before or after the numbers in the spreadsheet cell.
- Fixed an issue where when switching between views (i.e., Simple and Expert) sometimes the contents of the current data entry would become cut-off from the bottom of the screen. This only occurred when the screen was long enough to require vertical scrolling.
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| Enhancements | |
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| Fixes | - CVM: Core Questions template version 1.11 reflects updates to the Welcome Screen upon opening a submission. The new welcome screen displays the OMB Number expiration dates with an expiration end date of 2016. The CVM address line 1 has also been updated to reflect a corrected mailing address number. This change applies to all ONADE submissions.
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| Enhancements | |
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| Fixes | - CVM: Business Rules have been added to eSubmitter for the following submission types to show Reference Listed Product enabled and required: A-C-AC, A-C-CC, A-C-NL, A-C-NF, A-R-AC, A-R-CC, A-R-NL, A-R-NF, A-R-B1.
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| Enhancements | - CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CVM: The following templates were rolled back to the last version prior to the 9/12/13 release: INAD Major Technical Section (I-P-MC), JINAD Major Technical Section (J-P-MC), and ANADA Original (A-A-OT). As a result of the 9/12/13 release, questions become disabled (grayed out) preventing required information to be entered. The errors were introduced with the "two phased data submission" questions that were added to these templates. These questions will be added back to the templates in a future release.
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| Enhancements | - CTP: Updated the quantity fields in the CTP’s HPHC and Ingredient templates and import spreadsheets to allow for greater flexibility in data entry.
- CVM: Added HFV-160 to the LOV for Review Division on the Submission Type tab for all INAD H submissions.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CTP: Fixed an import issue on the HPHC template that was dropping the last picklist value upon import.
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| Enhancements | - All: Added new keyboard navigation support so that longer screens will auto-scroll vertically when tabbing through questions with the keyboard.
- All: Added new keyboard short-cut support to table screens (see the new Table option in the main menu for details).
- All: Added new keyboard outline support for navigating directly to a parent node (Ctrl->M).
- CDRH: Removed the password and embedded attachment validation from eCopies submissions.
- CDRH: Minor updates to the RadHealth templates.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CTP: Fixed an HPHC template issue related to Benzo[a]preen and Benzene and Smokeless products.
- CTP: Fixed an issue related the import of large numbers being converted to exponential notation.
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| Enhancements | - CVM: Additional question added to the I/P/MC, J/P/MC, and A/A/OT templates to support two phased CMC submissions.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | |
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| Enhancements | |
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| Fixes | - CTP: The CTP ESG Transmittal form’s list of submission types was updated.
- CBER: Minor update to the Investigational New Drug (IND) Application template.
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| Enhancements | - CVM: OMUMS submissions (I, L, N) are now active and are directed to the appropriate review division.
- CVM: Minor hint updates to Core Questions.
- CVM: Additional questions added for J/P/HF and I/P/HF.
- CTP: Added a new field to CTP’s ESG Transmittal Form which allows Industry to specify their submission type.
- CTP: Updated the CTP’s HPHC Import Spreadsheets to include an edition date.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | |
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| Enhancements | - CBER: Released CBER’s Investigational New Drug (IND) Application, including Antivenin INDs, in eCTD Structured Format.
- CDRH: Updated FDA Form Numbers in RadHealth templates.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - Updated CTP’s User Support phone number in all production templates.
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| Enhancements | |
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| Fixes | - CVM: Fixed minor issue with N-C-NL template.
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| Enhancements | - CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CVM: Minor updates to the following ONADE templates: Core Questions, Original ANADA (A/A/OT), Study Template (MC), Chemistry Report (B/F), Supplement (C), Reactivation of Supplement (R), Protocol (BQ), and Supporting Information (H).
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| Enhancements | - CDRH: Updated the Paperwork Reduction act statement in the Radhealth product report template.
- CDRH: Updated product code, guidance, and standards lookup tables.
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| Fixes | - CTP: Fixed an issues related to missing data and the Tobacco Registration and Listing and Product Ingredient Listing submission types.
- CDRH: Fixed an issue where contact/establishment addresses required a state/province/territory for international addresses when it should no longer be required.
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