Upcoming FDA regulations
This article was originally published in The Tan Sheet
Executive Summary
OTC documents slated for publication by the end of 1993 include a final monograph for OTC boil ointments, a tentative final monograph for OTC vaginal contraceptive products, a final rule on labeling of OTC drug products, an adverse reporting program for OTCS, and an amendment to the monograph for OTC wart remover products, according to FDA's "unified regulatory agenda" published in the Oct. 25 Federal Register. The document also indicates that FDA is close to publishing an advance notice of proposed rulemaking on the regulation of medical foods.
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