CDER Small Business & Industry Assistance (SBIA)

Register for Upcoming Events

Date	Time	Event	Location
May 20, 2025	1:00pm - 2:00pm	OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration	Webinar
May 7, 2025		FDA CDER Overview: Certificates of Confidentiality	On-Demand
May 6, 2025		CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications	On-Demand

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