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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
July 16, 2024 On Demand Office of Pharmaceutical Quality (OPQ) Reorganization Webinar
July 23, 2024 1:00 pm - 2:00 pm Introduction to FDA’s Office of Trade and Global Partnerships Webinar
July 30, 2024 2:00 pm - 3:30 pm Environmental Monitoring in Compounding Webinar
September 4, 2024 11:00 am - 3:00 pm FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA Webinar
September 12, 2024 8:45 am - 4:45 pm Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 Webinar
September 24 -25, 2024 8:30 am - 4:30 pm Advancing Generic Drug Development: Translating Science to Approval 2024 Workshop

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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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