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 |
---|---|---|---|
September 8, 2022 | 9:30 AM - 3:30 PM | Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act | Webinar |
September 20 - 21, 2022 | 8:00 AM - 5:10 PM | Advancing Generic Drug Development: Translating Science to Approval | Conference |
October 5, 2022 | 1:00 PM - 2:00 PM | Study Data Standards Update for CBER: Your Guide to a Successful Submission | Webinar |
October 11, 2022 | 8:50 AM - 3:10 PM | FDA NanoDay Symposium 2022 | Symposium |
October 26, 2022 | 1:00 PM - 4:00 PM | An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | Webinar |
Regulatory References, Training, and Resources
Regulatory References
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Contact SBIA
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
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