FDA REVIEW PROCESS

1 Each member of the review team CONDUCTS A FULL REVIEW of his or her section of the application. 2 FDA inspectors travel to CLINICAL STUDY SITES to conduct a ROUTINE INSPECTION. The Agency looks for evidence of fabrication, manipulation, or withholding of data. 3 The PROJECT MANAGER ASSEMBLES ALL INDIVIDUAL REVIEWS AND OTHER DOCUMENTS, such as the inspection report, into an “ACTION PACKAGE” This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official makes a decision.