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Diane Publishing Books
Food and Drug Administration: Approval and Oversight of the Drug Mifeprex
Marcia Crosse (au)
In Sept. 2000, the FDA approved the drug Mifeprex for use in terminating early term pregnancy. FDA approved the drug under a provision of its Subpart H regulations, allowing it to restrict the drug’s distribution to assure its safe use. Critics argued that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. This report: (1) describes FDA’s approval of Mifeprex, including the evidence considered and the restrictions placed on its distribution; (3) compares the Mifeprex approval process to the approval processes for other Subpart H restricted drugs; and (3) compares FDA’s post-market oversight of Mifeprex to its oversight of other Subpart H restricted drugs. Illustrations.
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