Accession Number : ADA311544

Title :   FDA Drug Approval: Review Time Has Decreased in Recent Years.

Corporate Author : GENERAL ACCOUNTING OFFICE WASHINGTON DC PROGRAM EVALUATION AND METHODOLOGY DI V

PDF Url : ADA311544

Report Date : OCT 1995

Pagination or Media Count : 46

Abstract : New drugs marketed in the United States must be approved first by the Food and Drug Administration (FDA). Approval comes after FDA has determined from data submitted by a drug's sponsor that the drug is safe and effective for use as indicated on its label and that the manufacturer can ensure its quality. Various parties calling for the legislative reform of FDA in recent months are concerned with the length of the approval process. Advocates of reform argue that shortening the time it takes to get new drugs approved will contribute both to public health, by making effective therapies available sooner to people who need them, and to the economic health of the pharmaceutical industry, by allowing drug manufacturers to sell their products sooner. Opposed to major reform, FDA claims that in recent years review time has been reduced considerably.

Descriptors :   *DRUGS, UNITED STATES, MANUFACTURING, ECONOMICS, HEALTH, TIME, PUBLIC HEALTH, LEGISLATION.

Subject Categories : Pharmacology
      Government and Political Science

Distribution Statement : APPROVED FOR PUBLIC RELEASE