CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

The CDER is the center in the FDA responsible for the following:

  • Acceptance and review of an investigational new drug application (INDA) prior to initiating a clinical trial;


  • Inspection of manufacturers and clinical trial participants (e.g. investigator site);


  • Review and issuance of drug approval;


  • Post-marketing surveillance of approved drugs.

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