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  1. Development & Approval Process | Drugs

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
November 30, 2022 8:30 AM - 4:00 PM Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Conference
December 7-8, 2022 11:00 AM - 2:40 PM FDA Clinical Investigator Training Course (CITC) 2022 Conference
December 14, 2022 2:00 PM - 3:00 PM What to Expect after an Inspection: 483s, Responses and Beyond Webinar
January 13, 2023 11:00 AM - 12:00 PM Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards Webinar
January 26, 2023 1:00 PM - 2:00 PM FDA’s Labeling Resources for Human Prescription Drugs Webinar

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Advisory Committees

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

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Contact SBIA

Contact Point
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

(301) 796-6707
(866) 405-5367

Hours Available

Center for Drug Evaluation and Research | CDER

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