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.
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our 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 August 4, 2016, 1 PM EST, CDER will host a LIVE webinar titled: "Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know."
Only 10 months until all DMFs must be submitted in electronic format!
This 90 minute webinar will provide information regarding the new requirement that all DMFs must be submitted in electronic Common Technical Document (eCTD) format starting May 5, 2017. The presentation will address issues such as:
- What are the eCTD specifications?
- Where to find helpful how-to materials on eCTD submissions?
- Tips for successful submissions.
- Presentation Slides
- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format â eCTD Specifications
- The eCTD website
- Electronic Submission of Drug Master Files Webinar