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Center for Drug Evaluation and Research

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Office Profile

Comprehensive profile of Center for Drug Evaluation and Research, including its role, location, and regulatory activities.

People (10)
Margarita Santiago
FDA_ASSOCIATED_PERSON
Donald D. Ashley
FDA_ASSOCIATED_PERSON
Joseph Salewski
FDA_ASSOCIATED_PERSON
Joshua S. Hunt
FDA_ASSOCIATED_PERSON
Khai Q. Nguyen
FDA_ASSOCIATED_PERSON
Susan F. Laska
FDA_ASSOCIATED_PERSON
Stacie A. Woods
FDA_ASSOCIATED_PERSON
Charles Franklin Stein
FDA_ASSOCIATED_PERSON
Teddi Lopez
FDA_ASSOCIATED_PERSON
Kassa Ayalew
FDA_ASSOCIATED_PERSON
Records (20)
WARNING_LETTER - Eugene Lefter

Drugs • November 16, 2009

WARNING_LETTER
WARNING_LETTER - Ruyan America, Inc.

Drugs • September 8, 2010

WARNING_LETTER
WARNING_LETTER - New Horizons LTD

Drugs • November 16, 2009

WARNING_LETTER
WARNING_LETTER - Pharmempire

Drugs • September 19, 2017

WARNING_LETTER
WARNING_LETTER - SmithKline Beecham Limited

Drugs • October 7, 2011

WARNING_LETTER
WARNING_LETTER - Tianjin Healthcare Medical Technology Co., Ltd.

drugs • October 29, 2026

WARNING_LETTER
WARNING_LETTER - Medsnoscript

Drugs • February 11, 2013

WARNING_LETTER
WARNING_LETTER - Randek l-warez

Drugs • November 16, 2009

WARNING_LETTER
WARNING_LETTER - Flu & Cold Defense LLC

Drugs • January 24, 2013

WARNING_LETTER
CRL - Eli Lilly And Company

BLA • December 17, 2021

CRL
CRL - Immunomedics, Inc.

BLA • January 17, 2019

CRL
CRL - Laurus Generics, Inc.

NDA (New Drug Application) • March 10, 2025

CRL
CRL - Santen Inc

Drugs • November 9, 2021

CRL
CRL - Accord Healthcare Inc.

NDA (New Drug Application) • December 5, 2024

CRL
WARNING_LETTER - Calaire Chimie S.A.S.

Drugs • July 18, 2014

WARNING_LETTER
WARNING_LETTER - www.buynetmeds.com

Drugs • June 12, 2025

WARNING_LETTER
CRL - Sarepta Therapeutics, Inc.

Drugs • August 19, 2019

CRL
CRL - Althera Life Sciences, LLC

Drugs • May 26, 2020

CRL
CRL - MedRx, Inc.

NDA (New Drug Application) • July 11, 2024

CRL
CRL - Hikma Pharmaceuticals USA Inc.

NDA (New Drug Application) • October 21, 2024

CRL

Showing 1 to 20 of 20 records

Guidance Documents (10)
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for Industry
Guidance
Regulatory Considerations for Prescription Drug Use-Related Software
Guidance
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle
Guidance
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators
Guidance
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers
Guidance
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry
Guidance
Study Data Technical Conformance Guide - Technical Specifications Document
Guidance
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
Guidance
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry
Guidance
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
Guidance
Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Center for Drug Evaluation and Research

Abbreviation

CDER

Country

USA

Postal Code

20993

State/Province

Maryland

City

Maryland

Address

10001 New Hampshire Avenue, Hillandale Building

Office Website

Visit Website

ID: cd980d74-1cbf-4226-ba9a-9045324c236c

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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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🇪🇺+48 532-447-507
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