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FDA AUTOMATIC APPROVAL DEADLINE FOR DRUG PRODUCTS SUGGESTED AT AMERICAN ENTERPRISE INSTITUTE SEMINAR; Rx-TO-OTC SWITCH "SUNSET LAW" PROPOSED

Executive Summary

FDA should have a legal deadline before which the agency can deny a drug approval and after which the drug would automatically be approved, according to Sam Peltzman, University of Chicago, and Peter Barton Hutt of the D.C. law firm Covington & Burling.

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