CDER Small Business & Industry Assistance (SBIA)

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April 19 - 20, 2023	1:00 PM - 2:30 PM	FDA’s Dosage and Administration Section of Labeling Draft Guidance	Webinar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

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 Learning Library on YouTube

Browse conference and webinar recordings on YouTube

Popular Topics

Guidances Related to Drugs

Documents representing FDA's thinking on a particular subject

Drug Approvals and Databases

Approvals and medications – Drugs@FDA, FDALabel, Orange Book, and more

Development & Approval Process

Drug applications, submissions, manufacturing, and small business help

Advisory Committees

Independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies

Contact SBIA

CDER Small Business and Industry Assistance
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

CDERSBIA@fda.hhs.gov

(301) 796-6707

(866) 405-5367

Center for Drug Evaluation and Research | CDER

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FDA Drug Information

Receive the latest drug information from the US FDA