RU-486 "approvable" decision occurs on Sept. 18 user fee deadline.
Executive Summary
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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