The Center for Drug Evaluation and Research (CDER) is the primary agency within FDA. Most of the activities which come to your mind regarding the FDA are located in the Center for Drug Evaluation and Research.
Some of the activities of CDER include:
1. Approving new drugs
2. Inspecting drug manufacturing facilities
3. Managing databases of drug information
4. Ensuring that all drugs are marketed and labeled according to the specific characteristics of the drug
5. Providing additional medical data about drugs which has been discovered after the drugs have been in use
6. Providing warnings and recalls of harmful drugs
7. Advising drug companies regarding clinical trials and manufacturing requirements
8. Communicating with the public, doctors, drug companies, health insurance companies, and legislators regarding a variety of FDA related topics.
Table of Contents
1. Author Overview of CDER and Drug Approval Process
2. Official Overview of CDER
3. List of Offices in CDER
4. Office of the Center Director
5. Office of Communications
6. FDA Drug Databases
7. Office of Compliance
8. Office of Compliance: Division of Surveillance
9. Office of Compliance: Division of New Drugs and Labeling
10. Office of Medical Policy
11. Office of New Drugs
12. Office of Oncology Drug Products (OODP)
13. Office of Pharmaceutical Science (OPS)
14. Pharmaceutical Science: Office of Testing and Research
15. Office of Surveillance and Epidemiology (OSE)
16. Office of Translational Sciences (OTS)
17. Appendix: Organizational Outline of CDER
