Browsing Harvard Law School by Keyword "expedited"
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A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients
(2005)After the passage in 1962 of the Kefauver-Harris Drug Amendments that mandated that the FDA grant premarket approval for all drugs and added a requirement that drug manufacturers demonstrate the efficacy of their products, ...