Center for Drug Evaluation and Research: Difference between revisions

=== 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

=== Office of Generic Drugs ===

This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms

=== 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 ===

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 ===

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 ===

This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs

=== 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 ===

This office ensures compliance with regulations relating to drug development and marketing