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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 24 -25, 2024 8:30 am - 4:30 pm Advancing Generic Drug Development: Translating Science to Approval - 2024: Earn 10.5 CE Hours Workshop
October 9, 2024 1:00 pm - 3:00 pm ICH M12 Drug-Drug Interaction Studies Final Guidance Webinar
October 16, 2024 1:00 pm - 2:30 pm Global IDMP Implementation - Getting Closer to the Goal Webinar
November 7, 2024 1:00 pm - 2:30 pm Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation 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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