Drugs

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

The 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.”disclaimer icon

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
 
 

 

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

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Page Last Updated: 02/24/2016
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