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FDA "pre-announced" inspection for drug industry supported by NDMA.

This article was originally published in The Tan Sheet

Executive Summary

FDA "PRE-ANNOUNCED" INSPECTIONS FOR DRUG INDUSTRY SUPPORTED by the Nonprescription Drug Manufacturers Association in a May 15 letter to FDA Associate Commissioner for Regulatory Affairs Ronald Chesemore. Noting the agency is considering expanding its pre-announced inspection program beyond the medical device industry to include the drug industry, NDMA says it "strongly supports the idea, and encourages the FDA to initiate it as soon as possible using the successful device program as the model."
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