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 |
---|---|---|---|
May 2, 2023 | 1:00 PM - 3:00 PM | Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” | Webinar |
April 25, 2023 | 3:00 PM - 4:30 PM | Electronic Systems, Electronic Records, and Electronic Signatures Webinar | Webinar |
April 19 - 20, 2023 | 1:00 PM - 2:30 PM | FDA’s Dosage and Administration Section of Labeling Draft Guidance | Webinar |
April 12 - 13, 2023 | 8:00 AM - 4:30 PM | Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF | Webinar |
Regulatory References, Training, and Resources
![Scientists in a lab working at a computer](https://public4.pagefreezer.com:443/content/FDA/30-04-2023T17:16/https://www.fda.gov/files/styles/medium_3/public/SBIA_WebGraphic_Lab02_1600x900_210910.png?itok=rlURbtDW)
Regulatory References
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
![laptop and open book in a library](https://public4.pagefreezer.com:443/content/FDA/30-04-2023T17:16/https://www.fda.gov/files/styles/medium_3/public/SBIA_WebGraphic_Library_1600x900_210910.png?itok=CCRdoWL2)
SBIA Learn Online Training Repository
Search for conferences, webinars, online courses, newsletters and podcasts
![network of people](https://public4.pagefreezer.com:443/content/FDA/30-04-2023T17:16/https://www.fda.gov/files/styles/medium_3/public/SBIA_WebGraphic_Network_1600x900_210910.png?itok=1x1FSqaD)
SBIA on LinkedIn
Stay connected and receive regulatory updates and event notifications
![video play button](https://public4.pagefreezer.com:443/content/FDA/30-04-2023T17:16/https://www.fda.gov/files/styles/medium_3/public/SBIA_WebGraphics_VideoPlay_210915_1526-4-1560x815.png?itok=BNPwV1yo)
SBIA Learning Library on YouTube
Browse conference and webinar recordings on YouTube
Paragraph Header
Contact SBIA
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
For Updates on Twitter follow
FDA Drug Information
Receive the latest drug information from the US FDA