CDER Small Business & Industry Assistance (SBIA)

Register for Upcoming Events

Date	Time	Event	Location
7/22/2026	1:00 to 2:00 p.m. ET	Panel Two - ClinicalTrials.gov: Essentials for Academic Medical Centers	Virtual
7/30/2026	1:00 to 2:00 p.m. ET	Panel Three - ClinicalTrials.gov: Essentials for Academic Medical Centers	Virtual
8/27/2026	8:30 a.m. to 12:30 p.m. ET	Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs	Virtual
9/29/2026	8:45 a.m. to 4:00 p.m. ET	FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates	Hybrid
Now Available	On-Demand	Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications	N/A
Now Available	On-Demand	Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data	N/A

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

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SBIA on LinkedIn

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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)

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FDA Drug Information

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