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  1. CDER Small Business & Industry Assistance (SBIA)

CDER SBIA Learn: Webinars, Conferences, Trainings



Welcome to CDER SBIA Learn. We offer a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry. Our offerings are organized by topic below.

Investigational New Drug Application (IND)
Clinical Trials
New Drug Application (NDA)
Communicating with FDA
Biologics and Biosimilars
Electronic Common Technical Document (eCTD) and Electronic Submissions Gateway (ESG)
Abbreviated New Drug Applications (ANDA) Submissions
Generic Drug User Fee Amendments (GDUFA)
Communications with FDA

Can’t find what you are looking for?
Contact the CDER SBIA staff.

(866) 405-5367
(301) 796-6707

Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

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