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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July 19-20, 2022 | 9:10 AM - 4:10 PM | Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites | Conference |
August 10, 2022 | 1:00 PM - 2:30 PM | Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use | Webinar |
August 11, 2022 | 9:30 AM - 12:30 PM | Best Practices for Topical Generic Product Development and ANDA Submission | Webinar |
Regulatory References, Training, and Resources
Regulatory References
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SBIA Learn Online Training Repository
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SBIA Learning Library 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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