WORLD OF GENERIC DRUGS MODULE

Post Marketing

Once a drug is approved, FDA continues to monitor that drug. Just like on the new drug side, any legitimate changes to an approved ANDA need to be known. The more significant the change -- brand or generic drug -- the more likely the company will require FDA's stamp of approval before the change can be implemented. The company can change the formulation, but it has to show FDA that it was controlled and demonstrate it is equivalent.

FDA has a reporting system for adverse events. There is a 15-day alert report of both serious and unexpected adverse events. Periodic adverse drug experience reports are done quarterly for the first 3 years post-approval and annually thereafter.