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GAO Plan B Report Expected In November; Judge May Order FDA Decision

This article was originally published in The Tan Sheet

Executive Summary

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 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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