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 |
|---|---|---|---|
| 5/5/2026 | 1:00 pm-2:00 pm ET | OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration | Virtual |
| 5/19/2026 and 5/20/29 | 9:00am-4:50 pm ET (Day 1) and 9:00-3:50 p.m. ET (Day 2) | Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products | In-Person and Virtual |
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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
Search for conferences, webinars, online courses, newsletters and podcasts
SBIA on LinkedIn
Stay connected and receive regulatory updates and event notifications
SBIA On-Demand Learning Library
Browse conference and webinar recordings on YouTube
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Contact SBIA
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Contact SBIA
Contact Point
CDER Small Business and Industry Assistance
Division of Drug Information
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
Division of Drug Information
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
(301) 796-6707
(866) 405-5367
Hours Available
Center for Drug Evaluation and Research (CDER)
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FDA Drug Information
Receive the latest drug information from the US FDA