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 |
---|---|---|---|
June 20, 2023 | 3:00 PM - 4:00 PM | Decentralized Clinical Trials (DCT) Draft Guidance | Webinar |
June 5-9, 2023 | 8:40 AM - 4:30 PM | Regulatory Education for Industry (REdI) Annual Conference 2023 | Conference |
May 24, 2023 | 9:00 AM - 2:00 PM | An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) | Webinar |
May 16, 2023 | 1:00 PM - 2:00 PM | OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration | Webinar |
May 15, 2023 | 1:00 PM - 4:30 PM | A Deep Dive: GDUFA III Scientific Meetings | 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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