More Information on the Center For Drug Evaluation and Research
Inside the FDA: The Center For Drug Evaluation and Research
Article from FDA Consumer discussing the responsibilities of CDER, including high quality reviews and post marketing responsibilities.
Fact Book From The Center For Drug Evaluation and Research
Provides an overview of the diversity of activities and responsibilities within the Center.
Fact Sheet [HTML] [PDF]
Provides information on CDER's strategic initiatives
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.
A Brief History of the Center For Drug Evaluation and Research
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 Small Business Assistance
This site help small businesses understand the CDER's structures and rules.
CDER Reference Guide
Includes information on organizational charts, telephone numbers, key officials, and abbreviations
CDER Handbook
Provides 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
Provides links which may be useful to manufacturers of drugs.
CDER Guidance Documents
Guidance documents represent the Agency's current thinking on a particular subject.
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.
