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Consumer OTC Drugs

GMP failure alerts under NDA/ANDA requirements is becoming OTC issue -- W-L exec.

This article was originally published in The Tan Sheet

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Executive Summary

NDA/ANDA FIELD INVESTIGATION ALERTS BECOMING RELEVANT TO OTC MANUFACTURERS as a result of the growing number of Rx-to-OTC switches, Warner-Lambert Consumer Sector Quality Director Anthony Panzica pointed out at the Nonprescription Drug Manufacturers Association's annual manufacturing controls seminar in Philadelphia on Oct. 19. Observing that notification of stability failures has "not been a big deal" for OTC drug manufacturers, Panzica predicted that field alerts are likely to become a "real burden" in the future.

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