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Center for Drug Evaluation and Research: Difference between revisions
Center for Drug Evaluation and Research (view source)
Revision as of 22:57, 9 January 2025
, 9 January→Office of New Drugs
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=== Office of New Drugs === | === Office of New Drugs === | ||
This office is responsible for oversight of clinical trials and other studies during drug development, and for the evaluation of new drug applications | |||
The Office of New Drugs is divided into several departments based on the indication of the drug (the medical need for which it is being proposed) | |||
=== Office of Generic Drugs === | === Office of Generic Drugs === | ||
This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms | |||
=== Office of Strategic Programs === | === Office of Strategic Programs === | ||
This office is responsible for business programs, represents CDER in the FDA Bioinformatics Board, and communicates with other agencies | |||
=== Office of Pharmaceutical Quality === | === Office of Pharmaceutical Quality === | ||
This office is responsible for integrating assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. | |||
=== Office of Surveillance and Epidemiology === | === Office of Surveillance and Epidemiology === | ||
This office is responsible for post-marketing surveillance to identify adverse effects that may not have been apparent during clinical trials, using the [[MedWatch]] program | |||
=== Office of Translational Sciences === | === Office of Translational Sciences === | ||
This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs | |||
=== Office of Medical and Regulatory Policy === | === Office of Medical and Regulatory Policy === | ||
This office develops and reviews guidelines pertinent to CDER's mission of ensuring the safety of drugs | |||
=== Office of Compliance === | === Office of Compliance === | ||
This office ensures compliance with regulations relating to drug development and marketing | |||
==History== | ==History== | ||