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FDA Memo Sheds Light On Plan B Discussions

This article was originally published in The Tan Sheet

Executive Summary

FDA received a dual Rx/OTC marketing plan from Barr for its emergency contraceptive Plan B several weeks before issuing a "not approvable" letter last spring, an internal agency memorandum reveals

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FDA's interest in establishing an official third class of drugs, as well as the OTC industry's concern about the idea, could be diminished because the agency already allows a path to behind-the-counter sales in new drug and switch applications, according to a former FDA chief counsel

Behind-The-Counter Sale Works Without Regulation – Former FDA Counsel

FDA's interest in establishing an official third class of drugs, as well as the OTC industry's concern about the idea, could be diminished because the agency already allows a path to behind-the-counter sales in new drug and switch applications, according to a former FDA chief counsel

Behind-The-Counter Sale Works Without Regulation – Former FDA Counsel

FDA's interest in establishing an official third class of drugs, as well as the OTC industry's concern about the idea, could be diminished because the agency already allows a path to behind-the-counter sales in new drug and switch applications, according to a former FDA chief counsel

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