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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
September 6, 2023 1:00 pm - 3:00 pm Understanding FDA Inspections and Data Webinar
September 13 - 14, 2023 9:00 am - 5:00 pm Advancing Generic Drug Development: Translating Science to Approval 2023 Conference
September 18 - 19, 2023 9:00 am - 5:15 pm Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials Conference
September 28, 2023 8:45 am - 4:45 pm Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 Conference
October 11, 2023 8:50 am - 2:50 pm 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials Symposium

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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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