The Center for Drug Evaluation and Research's (CDER) job is to ensure that
drugs are safe and effective. (See "From Test Tube To Patient: Protecting America's Health Through Human Drugs"). CDER does not test drugs, although the
Center's Office of Testing and Research does conduct limited research in the areas of drug
quality, safety, and effectiveness. More...
Drug Approval Process Featured Items
Investigational New Drug (IND)
IND Application Process - includes pre-IND consultation program information, forms and instructions
CDER Drug Product Applications - includes information on submitting applications for a regular or an emergency investigational drug product, a new drug, or a generic drug
