U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. CDER Small Business & Industry Assistance (SBIA)
  5. CDER Small Business and Industry Assistance (CDER SBIA) Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
  1. CDER Small Business & Industry Assistance (SBIA)

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016

NOTE: On April 7, 2017 the FDA announced that it is extending the compliance date for submitting DMFs in eCTD format to May 5, 2018. These webinars were created prior to April 7, 2017 and have the incorrect DMF compliance date.

Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to launch our 2016 webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On February 4, 2016, CDER hosted a LIVE webinar titled: "New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know.”

This 75 minute webinar provided information regarding the new requirement that all DMF Submissions be submitted in electronic Common Technical Document (eCTD) format starting May 5, 2017. The presentation also addressed issues such as:

  • What are the eCTD specifications?
  • Where to find helpful how-to materials on eCTD submissions?
  • Tips for successful submissions.
 
The featured speakers were:
 
Jonathan Resnick
Project Management Officer,
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP), CDER
 
Arthur Shaw
DMF Expert, Review Chemist,
New Drugs Products Branch IV (NDBIV),
Division of New Drug Products (DNDPII),
Office of New Drug Products (ONDP),
Office of Pharmaceutical Quality (OPQ), CDER
 
Ginny Hussong
Director,
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP), CDER
 
 

 

Presentation Information

ResourcesForYou

 
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

If you've never used Connect Pro, get a quick overview: http://www.adobe.com/go/connectpro_overview

Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

 

Back to Top