Generic Drug Review Process
Every discipline involved in the review has an equal voice to report what they are seeing with the drug in question. At the end of the process, each discipline must agree that the drug meets requirements. Clinicians are not represented in this process because very little clinical evaluation is done on generics. FDA uses bioequivalence as a substitute.
A clinical study is needed for a nontraditional dosage form. If the product is non-systemically absorbed, then clinical studies of several dozen patients over some finite period of time will need to be performed. The key concept is that the process, rules and regulations are locked in tightly. The generic review team and the organizational structure are designed to determine whether or not the company can manufacture the drug and verify that the drug behaves the same through bioequivalence.
