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 |
---|---|---|---|
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 |
August 16 - 18, 2022 | 8:30 AM - 12:30 PM | Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines | Conference |
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 |
Regulatory References, Training, and Resources
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Regulatory References
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
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SBIA Learn Online Training Repository
Search for conferences, webinars, online courses, newsletters and podcasts
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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
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10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
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