CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation
Register for Upcoming Events
| Date | Time | Event | Location |
|---|---|---|---|
| February 15, 2023 | 1:00 PM - 2:00 PM | Overview: Clinical Pharmacology Considerations for Neonatal Studies | Webinar |
| February 24, 2023 | 1:00 PM - 4:30 PM | Joint US FDA – Health Canada ICH Public Meeting | Webinar |
| March 14, 2023 | 10:00 AM - 12:00 PM | A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence | Webinar |
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Regulatory References, Training, and Resources
Regulatory References
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
SBIA Learn Online Training Repository
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SBIA on LinkedIn
Stay connected and receive regulatory updates and event notifications
SBIA Learning Library on YouTube
Browse conference and webinar recordings on YouTube
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Contact SBIA
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Contact SBIA
Contact Point
CDER Small Business and Industry Assistance
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
(301) 796-6707
(866) 405-5367
Hours Available
Center for Drug Evaluation and Research | CDER
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FDA Drug Information
Receive the latest drug information from the US FDA