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All: To maintain compliance with FDA standards, eSubmitter has now incorporated the Geopolitical Entities, Names, and Codes (GENC) Standard for countries and subdivisions. For more information, see the eSubmitter "Alerts and News" section.
1. ONADE: Updated the Food Use Authorization templates for submission types (I/J-D/O-OT) to include the following changes:
Submission type options related to dosage form, route of administration, and target animal are now derived from the product description section.
Prevent submission from packaging when sponsor is unable to certify that treated animals will remain under investigational conditions and under supervision for the established drug investigational withdrawal period.
Updated hint related to waiver request.
Updated language to align with P&P 1243.4040 and investigational food-use authorization letters.
2. ONADE-ABCT: Added the three Expanded Conditional Approval (XCA) submissions types (I-G-DE, I-P-XE, I-E-XE).
ONADE: Provided access to the Product Book without requiring a submission to be opened.
ONADE: Revised the General Correspondence - Termination submission types (J/I/G-G-TM) to improve clarity regarding the certification responses.
Fixes
ONADE and OSC: Fixed an issue where an edit dialog was accessible from the selected item of a multi-file attachment list that is no longer needed within templates supporting the improved file attachment approach.
ONADE: Fixed an issue where the submission correspondence date was missing from within the submission package when using the new digital signature approach during packaging.
ONADE: Added a new option that allows the Responsible Official to digitally sign the Administrative Cover Sheet externally from eSubmitter and have it attached during the submission packaging step. Using this new option, the Responsible Official does not need to be present during the submission packaging process. The pre-existing option of digitally signing a submission during the packaging step is also still available.
All: Added a 100-character limit constraint to the length of attached file names within eSubmitter.
ONADE-ABCT: Updated section 1.0 of the Human Food Safety Technical Section (I-P-HF) to support multiple components (i.e., Toxicology, Residue Chemistry, Microbial Food Safety) within a single submission.
OSC-DER: Updated the DER Core template to support the revised eSubmitter file attachment approach that ensures unique file names and prevents special characters within file names.
ONADE: Updated the Notice of Shipment (B) submission type (I/J-B-OT) to include revised acknowledgment text in section 3.0, as well as adjusted the target animal question in section 1.2 to derive its options from the product description section.
ONADE: Revised the message when selecting a VMF file type within section 6.0 Submission Type Code to include Import Tolerance.
Fixes
All: Fixed the HTML tagging issue within the output of the eSubmitter Missing Data/Validation Issues report.
ONADE: Fixed an issue within the Notice of Shipment (B) submission type (I/J-B-OT) that resulted in some sections being incorrectly enabled when reopening a submission file.
ONADE: Fixed an issue that incorrectly disabled section 2.6 Labeling of a B1 Supplement (N-C-B1) submission.
ONADE: Fixed an issue where the Determination of Eligibility (I-G-DE) template did not include the revised product description section.
ONADE/ONADE-ABCT: Added, updated, and reorganized various options within sections 1.0, 2.0 and 4.0 of the Human Food Safety Technical Section submission type (I-P-HF).
ONADE: Revised questions related to patents in section 2.1 "Additional Reference Listed Product Description" of the submission type (J-A-OT) to reflect patents expired and unexpired in the Green Book at FDA.
Fixes
ONADE: Fixed an issue where the purpose of submission selection was not retained after closing and reopening General Correspondence/Supplement Administrative Request submission types for ANADA/NADA document types (A/N-G/C-AD).
ONADE: Fixed the amendment section options across various submission types to reflect the reorganization that moved the production description before the submission details.
ONADE: Fixed the submission type to establish a new JINAD file (J-A-OT) to remove redundant questions that remained after the product description was moved to before the submission details.
ONADE: Fixed an issue that prevented packaging of a Notice of Shipment (B) submission type (I/J-B-OT).
OSC DER: Updated the physical address of the Document Control Unit (DCU) displayed within DER templates.
Fixes
ONADE: Fixed an issue where the product description section could no longer be disabled from within a GC-A-OT submission when the content included is not related to a specific drug product.
ONADE ABCT: Removed the question supporting a VIP enrollment request when creating I-A-OT and V-A-OT submissions specific to only Gene Therapy (GT) products.
ONADE: Provided an option for sponsors to attach a letter from CVM granting a biowaiver within J-P-BQ and A-A-OT submissions, thereby removing the requirement to provide blood level bioequivalence study information within the submission.
ONADE: Added support for attaching multiple files to the Final Study Report (FSR) question within J-P-BQ submissions.
Fixes
ONADE: Fixed an issue within section 2.3 "Test and Control Article Characterization" of I-P-EF and I-P-TS submissions that resulted in the potential loss of information when multiple study types were included.
ONADE: Fixed an issue with the total quantity and concentration shipped question within section 2.0 "Shipment or Receipt Information" of an I-B-OT submission that was identified after the new product description deployment.
ONADE: Corrected a defect within the Notice of Shipment template (I-B-OT) where the question requesting information on the total quantity and concentration of drugs shipped was missing from the template after the new product description was deployed.
ONADE: Corrected a defect within the Original VMF template for CMC (V-A-OT) where the product description template was inadvertently loaded when it shouldn’t have been after the new product description was deployed.
ONADE: Included new Product Book/Product Description capabilities to improve how product description information is collected for ONADE submissions and how the information is managed by industry stakeholders.
ONADE: Adjusted the N/I-Z-OM template for Pre-Submission Conference requests to help the primary reviewer determine when the Division of Human Food Safety (HFV-150) should be consulted for the purpose of a Human User Safety evaluation.
OSC-DER: Updated hyperlinks within OSC-DER templates to reflect recent changes in URL addresses within FDA.
Fixes
ONADE: Corrected a defect within the Notice of Shipment template (I-B-OT) to no longer require sections for Notice of Claimed Investigational Exemption (NCIE), imports, and shipment type information for minor species reports that are submitted in batched shipment notices.
ONADE: Updated language within section 6.2 "Pre-submission Conference" of the Request for Meeting submission types (I-Z-OM and N-Z-OM), so sponsors will have clearer language to communicate to CVM the desired scope of the pre-submission conference meeting.
ONADE: Removed the Early Information (EI) question from the INAD Request for Meeting submission type (I-Z-OM), since ONADE will no longer be accepting meeting submissions for EI under the INAD document type.
ONADE: Added a warning message to the creation of General Correspondence (G) document types to explain that these are typically used for submitting pre-INAD information, waiver requests, and other less common type of submissions; and if the sponsor needs to submit a general correspondence submission for an existing file or application (i.e., NADA, INAD, ANADA, JINAD, VMF), they should select the appropriate document type and General Correspondence as the submission type.
ONADE: Removed the reference to "Guidance for Industry 42" (GFI 42: Animal Drug Manufacturing Guidelines) from submissions containing the major technical section for Chemistry, Manufacturing and Controls (CMC) until further notice.
ONADE: Incorporated new updates into the Bioequivalence Protocol (J-E-BQ) template.
Fixes
ONADE: Corrected a defect within the core template where the submission classification codes (SCC) were not properly resetting when changing the user fee type of a user fee waiver request submission.
ONADE: Included a new announcement within the "Alerts and News" section of the eSubmitter introductory screen regarding new waiver submission types and added new message text and updated hints within the Submission Type Selection section to aid in selecting the correct waiver type.
Fixes
ONADE: Corrected a defect in the Paragraph III Certification for the A-A-OT and A-E-OT templates under Section 3.0 Patent Certification and Marketing Exclusivity.
All: Updated the CVM mailing address within the eSubmitter Account Registration Quick Guide.
OSC-DER: Included a new announcement within the "Alerts and News" section of the eSubmitter introductory screen regarding the OSC DER Digital Signature Requirement.
