GAO Plan B Report Expected In November; Judge May Order FDA Decision
This article was originally published in The Tan Sheet
The Government Accountability Office will issue its final report on the investigation into Barr's Plan B switch application by the end of November, according to congressional staffers who have reviewed the draft report
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FDA Office of Women's Health Director Susan Wood is resigning over the agency's handling of Barr Labs' application to switch its Plan B emergency contraceptive over-the-counter
FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B
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