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

[ Vol. 3 , Issue. 3 ]


Priti J. Mehta and Chandni K. Doshi   Pages 142 - 150 ( 9 )


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.

Conclusion: The reporting of adverse events constitutes an important function of the pharmacovigilance department as it contributes to identification of certain adverse events which were previously unknown. Identification of any new adverse drug event may necessitate further regulatory actions by FDA such as label changes, market withdrawal depending on its severity. Non-compliance to postapproval safety reporting may result in suspension of marketing approval of the drug product by the FDA.


US FDA, safety reporting, pharmacovigilance, individual case safety report, periodic adverse drug experience report.


Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad-382481, Gujarat, India.

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