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 |
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November 30, 2022 | 8:30 AM - 4:00 PM | Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions | Conference |
December 7-8, 2022 | 11:00 AM - 2:40 PM | FDA Clinical Investigator Training Course (CITC) 2022 | Conference |
December 14, 2022 | 2:00 PM - 3:00 PM | What to Expect after an Inspection: 483s, Responses and Beyond | Webinar |
January 13, 2023 | 11:00 AM - 12:00 PM | Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards | Webinar |
January 26, 2023 | 1:00 PM - 2:00 PM | FDA’s Labeling Resources for Human Prescription Drugs | Webinar |
Regulatory References, Training, and Resources
Regulatory References
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Contact SBIA
Division of Drug Information
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10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
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