Drug Industry Resource Center

Industry Specific Definitions

This page defines compliance terms and acronyms used by the drug industry.

Overview of the US Pharmaceutical and Medicine Manufacturing Industry

Provided by the US Department of Labor, Bureau of Labor Statistics

About the FDA Center for Drug Evaluation and Research
American consumers rely on CDER to facilitate the availability of safe and effective drugs, keep unsafe or ineffective drugs off the market, improve the health of Americans, and provide clear, easily understandable drug information for safe and effective use.  CDER is involved in four major activities: New Drug Development and Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities.

CDER Fact Sheet - Improving Public Health:  Promoting Safe and Effective Drug Use  [HTML] [PDF]
This brochure describes what CDER does, and some strategic focuses of the center.

CDER Frequently Asked Questions
This page provides answers to 18 frequently asked questions regarding CDER, its activities, and consumer concerns.

CDER Reference Guide
This page provides contact information for key various departments and officials within CDER, and a list of standard abbreviations.

History of CDER
This story summarizes some of the dynamics involved in the history of the drug regulatory function at FDA, especially with respect to the many organizational upheavals this function experienced over the past 90 years.

CDER Organizational Chart
This site provides an organizational chart for the Center for Drug Evaluation and Research, with links to the home pages of the various divisions.

Key CDER Officials
This document provides the names, telephone numbers, mailing addresses, and office locations of key officials at CDER.

Fact Book From The Center For Drug Evaluation and Research -  
This publication provides an overview of the diversity of activities and responsibilities within the Center.

Inside the FDA:  The Center For Drug Evaluation and Research 
This article from FDA Consumer discusses the responsibilities of CDER, including high quality reviews and post marketing responsibilities.

Inside the FDA: The Center For Drug Evaluation and Research - Why Should FDA Regulate Drugs? 
In this article from FDA Consumer, Janet Woodcock, Director of CDER, is interviewed and provides her views on subjects including why drugs need to be regulated, CDER reform, drug labeling, and access to investigational drugs.

CDER Handbook
The CDER Handbook was developed to provide a user-friendly resource on the World Wide Web for obtaining information on the Center's processes and activities of interest to regulated industry, health professionals, academia, and the general public.

CDER's Industry Information  for Drug Manufacturers
This site provides links which may be useful to manufacturers of drugs.

CDER Web Site
Click here to go to CDER's web site.

CDER Ombudsman
In CDER, the Ombudsman has responsibilities in addition to resolving disputes. These include getting feedback from inside and outside the Center about the effectiveness of programs and about problems that impede CDER's performance of its mission or conflict with its values/operating principles. The Ombudsman also advises the Center Director on ways to correct such problems.

Drug Regulatory Issues

Final Report on Pharmaceutical Manufacturing Initiative Issued

Presentation:  Pharmaceutical Quality by Design: Improving Emphasis on Manufacturing Science in the 21^st Century, [PDF] Ajaz S. Hussain, Ph.D., CDER.

The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective  
This article from FDA Consumer explains the process, which consists of 12 steps, by which a new drug is approved.  It also addresses the role that user fees play in the approval process.

Presentation:  The FDA Process for Approving Generic Drugs, Gary J Buehler, R.Ph., Director, Office of Generic Drugs
This presentation consists of 53 slides discussing issues involved with approving generic drugs.

Why Drugs Get Pulled Off The Market  
This FDA Consumer article explains how CDER handles adverse event reports, and how a drug can have its approval withdrawn if there are rare, unpredictable problems, if it is more toxic than expected, if it is regularly misused, if it proves to be dangerous in combination with other drugs, or if safer alternatives become available.

FDA's Summary of Judge Wolin's Interpretation of GMP Issues Contained In the Court's Ruling in USA vs Barr Laboratories
This is a summary of the impact of USA v. Barr Laboratories on FDA.

The Barr Decision Court Document
This is a copy of the decision made in USA v. Barr Laboratories.

Radiofrequency Identification Technology:  Protecting the Drug Supply an article from FDA Consumer.