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 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 |
May 29-30, 2024 | 8:30 am - 4:30 pm | Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development | Conference |
June 13, 2024 | 9:00 am - 11:30 am | OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites | Webinar |
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
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SBIA Learning Library on YouTube
Browse conference and webinar recordings on YouTube
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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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FDA Drug Information
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