The FDA review team is multidisciplinary, yielding different types of reviews. Medical reviews are usually authored by physicians who summarize and evaluates the data on drug efficacy and safety. Statistical reviews are carried out by statisticians who test whether they can replicate the sponsor’s results using the patient-level data submitted electronically. There are other review disciplines, e.g. chemistry, pharmacology-toxicology, whose reviews pertain primarily to the preclinical phase and early clinical (human) phases of drug development.
