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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
October 5, 2022 1:00 PM - 2:00 PM Study Data Standards Update for CBER: Your Guide to a Successful Submission Webinar
October 11, 2022 8:50 AM - 3:10 PM FDA NanoDay Symposium 2022 Symposium
October 26, 2022 1:00 PM - 4:00 PM An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations Webinar
November 30, 2022 8:00 AM - 4:30 PM Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Conference

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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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