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 |
|---|---|---|---|
| April 10 - 11, 2024 | 8:30 am - 5:00 pm | Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access | Conference |
| April 25, 2024 | 1:00 pm - 4:00 pm | Facilitating Generic Drug Product Development through Product-Specific Guidances | Webinar |
| May 9, 2024 | 1:00 pm - 3:30 pm | Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval | Webinar |
| May 16, 2024 | 1:00 pm - 2:30 pm | Statistical Considerations for Premarketing Risk Assessment | 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
Search for conferences, webinars, online courses, newsletters and podcasts
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
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