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OTC division's new responsibilities under FDA guidelines should be phased in -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

FDA OTC DIVISION PHASE-IN OF Rx-TO-OTC SWITCH POST-APPROVAL OVERSIGHT urged by the Nonprescription Drug Manufacturers Association in an Aug. 16 letter to Murray Lumpkin, MD, deputy director for review management at FDA's Center for Drug Evaluation & Research. Commenting on a recently released draft of FDA internal guidelines that would expand the OTC division's purview over NDAed OTCs, NDMA suggested "staged implementation of [the division's] responsibilities in the post-approval oversight of OTC NDAs (e.g., starting with ODE V) in order to ensure a smooth stepwise implementation."

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