The Mifepristone Story So Far: Tracing The Origins Of The Legal Fight Over The Abortion Pill
Timeline depicts the 27-year history of mifepristone from new drug application submission through an advisory committee vote, REMS changes, and legal challenges. With the product headed back to the Supreme Court, FDA's approval authority in general is also on the docket.
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Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.
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