RU-486 "approvable" decision occurs on Sept. 18 user fee deadline.
RU-486 DECISION DEADLINE COINCIDES WITH CONGRESSIONAL DEBATE on President Clinton's veto of a ban on partial birth abortions. The confluence of FDA's publicly stated Sept. 18 deadline for a decision on the abortifacient and the Congressional attention to the veto gave political resonance to FDA's decision to grant "approvable status" to mifepristone. Following the advisory committee review of mifepristone in July, FDA Commissioner Kessler declared the agency would make a decision by the six-month user fee deadline of Sept. 18 ("The Pink Sheet" July 22, p. 3).
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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