Regulatory Aspects of Post-Approval Safety Reporting for Generic Drug Products in the US

Abstract

Background: Generic drugs are those that are identical or bioequivalent to a brand name drug or innovator drug in active ingredient(s), dosage form, strength, route of administration, intended use, quality, safety and performance characteristics. Pharmaceutical companies need to submit Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market a generic product in the US. After a drug product is marketed, it is mandatory for pharma companies to report adverse events occurring due to their drug products to the FDA and this is done by the Pharmacovigilance department. The objective of this article is to provide an understanding of the pharmacovigilance department and the activities conducted by them to report adverse events to the FDA and the challenges faced by them while carrying out these activities. Keywords: US FDA, safety reporting, pharmacovigilance, individual case safety report, periodic adverse drug experience report.