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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

DateTimeEventLocation
January 22, 20251:00 pm - 3:00 pmBsUFA III Regulatory Science Pilot Program: Progress UpdateWebinar
January 29, 20259:00 am - 4:30 pmKnowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDAConference
February 11, 202511:00 am - 3:00 pmJoint US FDA – Health Canada ICH Public Meeting 2025Webinar
April 9-10, 20258:30 am - 5:00 pmGeneric Drugs Forum (GDF) 2025: Book Your Special Rate Room by March 11Conference

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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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