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.

CDER is making available the webinar "What’s New with Forms FDA 3542a and 3542?" which provides an overview of the changes to Forms FDA 3542a and 3542 and walk through Form FDA 3542 using mock data.

Speakers:

CDR Kendra Stewart, R.Ph., Pharm.D.
Supervisor, Orange Book Team
Division of Legal and Regulatory Support (DLRS)
Office of Generic Drug Policy /Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

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

Resources

• View Webinar
• What’s New with Forms FDA 3542a and 3542 PDF
• Orange Book
• CFR Search
• MMA Final Rule
• MMA
• FDA Forms

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