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Regulatory News
6 March 2012
by Alexander Gaffney, RAC

FDA Releases Report on Postmarketing Study Requirements

The US Food and Drug Administration (FDA) released a report 6 March on the postmarketing studies required of sponsors for products approved under the terms of the FDA Amendments Act (FDAAA) of 2007. The act allows FDA to mandate certain postmarketing requirements (PMRs) and postmarketing commitments (PMCs) of sponsors to further assess known risk, signals of serious risk or identify unknown risks.

The report notes that the majority of PMRs (87%) and PMCs (75-80%) are on schedule. Most of the requirements that are not on schedule are relatively recent (92% within 3 years). Fourty-nine percent of unfulfilled obligations are for pediatric study. Biological products also accounted for 49% of all pending PMRs.


Read more:

FDA - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments

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