Small Business Assistance
The FDA’s Center for Drug Evaluation and Research (CDER) supports a Small Business and Industry Assistance (SBIA) program that promotes productive interactions with regulated industry by aiding national and global small businesses (defined as businesses with fewer than 500 employees) in receiving information pertaining to the development and regulation of human drug products.[1] The FDA provides a wealth of information to small businesses, which can be accessed through the CDER SBIA Learn webpage. Key topics of interest the source spotlights include:
- SBIA Multimedia Resources and Offerings
- Over-the-Counter Drug Regulation
- New Drug Development and Safety
- Regulatory Submissions
- Generic Drugs
- Registration and Listing
- Drug Supply Chain
- Import-Export
- Drug Quality
- BioResearch Monitoring Program, Drug Master File, Compounding, Drug Shortages
- Related Presentations and Webinars
CONFERENCES AND WORKSHOPS
Information about SBIA conferences and workshops is available here.
POINTS OF CONTACT
Brenda Stodart, Pharm.D.
CDER Small Business Assistance
Center for Drug Evaluation and Research
(301) 796-6707
CDERSmallBusiness@fda.hhs.gov
Brenda.stodart@fda.hhs.gov
Virginia Behr
CDER Ombudsman
Center for Drug Evaluation and Research
(301) 796-3436
cderombudsman@fda.hhs.gov
virginia.behr@fda.hhs.gov
CDER Key Officials
A list of key officials within CDER is available here.
Updated by Theresa Pipher, November 2020
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