Also known as a “Clinical review” or “Medical review”. As one part of the FDA’s process for evaluating marketing applications for new medicines (e.g. a New Drug Application or Biologics License Application), a medical officer, usually a physician, performs a review of and prepares a report regarding the clinical aspects of the application. These reports generally contain a listing of clinical studies included in the application and information about the design and results of those trials, including analyses conducted independently by the medical officer and additional commentary. Medical officer reviews are made public under FOIA and are posted to the FDA’s website (for drugs, under the Drugs@FDA database and for biologics, by searching the “Vaccines, Blood & Biologics” section of the FDA’s website).
Example: Gardasil clinical review (source)
See also bevacizumab clinical review part 1
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