CDER Small Business & Industry Assistance (SBIA)

Register for Upcoming Events

Date	Time	Event	Location
4/22/2026 and 4/23/2026	9:00 am-5:00 pm ET	Generic Drugs Forum (GDF) 2026	In-Person and Virtual
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

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

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
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993

CDERSBIA@fda.hhs.gov

(301) 796-6707

(866) 405-5367

Center for Drug Evaluation and Research (CDER)

For Latest Updates Follow

FDA Drug Information

Receive the latest drug information from the US FDA