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GENERIC DRUG REGULATION

This article was originally published in The Gold Sheet

Executive Summary

...is being closely examined at FDA and the U.S. Pharmacopeia in the search for ways to streamline the approval process and update the standards to match current manufacturing science. FDA’s generics office is implementing a range of strategies aimed at reducing ANDA approval times and addressing workload issues including early review of dissolution testing and eliminating re-reviews of drug master files. Dissolution methods for alternate dosage forms and better coverage of marketed substances and products by USP monographs are other facets of the effort to clarify the regulatory standards for generic products. At a recent USP conference, participants explored the current problems drug product manufacturers face in assuring that excipients will serve the more complex purposes for which they are being used. USP excipient initiatives include updating its guidance on pharmaceutical water.

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