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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
March 29, 2022 2:00 - 3:00 PM OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings Webinar
March 16, 2022 10:00 - 11:30 AM FDA-EMA Parallel Scientific Advice (PSA) Program Webinar
February 24, 2022 1:00 - 3:00 PM Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Webinar
February 16, 2022 1:00 - 3:30 PM CDER BIMO GCP Compliance and Enforcement 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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