Drugs

CDER SBIA Learn

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.

Overview 
Investigational New Drug Application (IND)
Clinical Trials
New Drug Application (NDA)
Communicating with FDA
Safety
Biologics and Biosimilars
Other
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
CDERSBIA@fda.hhs.gov

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

Page Last Updated: 02/06/2017
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