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OTC anticaries biological testing plan requested by FDA in petition response.

This article was originally published in The Rose Sheet

Executive Summary

OTC ANTICARIES BIOLOGICAL TESTING SCHEDULE REQUIRED BY FDA before it will make a final decision on extending the effective date of the biological testing requirements in the OTC anticaries final monograph by 12 months to Oct. 7, 1997. The petition requested the extension in order to provide Nonprescription Drug Manufacturers Association and Cosmetic, Toiletry and Fragrance Association members sufficient time to comply with the requirements and to provide reference standards to the U.S. Pharmacopoeia for formulas included in the final monograph ("The Rose Sheet" April 7, p. 15). FDA informed NDMA of its decision in a May 24 letter, which responds to an April 17 citizen petition submitted on behalf of an NDMA/CTFA joint task force.

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