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FDA's unusual Plan B review.(POLICY & PRACTICE)
The FDA's decision in 2004 not to approve the emergency contraception product Plan B for over-the-counter sale was not typical of the 67 other prescription-to-OTC switch decisions made by the agency between 1994 and 2004, according to a report from the Government Accountability Office (GAO). The FDA denied an application to approve Plan B for OTC sale in May 2004 saying that officials had safety concerns about the use of the product in women aged under 16 years. Among the differences is that FDA officials took the rare step of not approving the Rx-to-OTC switch against the advice of its agency's own advisory committee, which had voted to recommend ...
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Source: HighBeam Research, FDA's unusual Plan B review.(POLICY & PRACTICE)