Accession Number : ADA290109

Title :   Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System,

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

Personal Author(s) : Chan, Kwai-Cheung

PDF Url : ADA290109

Report Date : 28 APR 1992

Pagination or Media Count : 6

Abstract : Our study examined the critical regulatory areas associated with nonprescription drugs--approval for marketing, quality assurance in manufacturing, and monitoring for adverse effects after marketing. With regard to the approval process, there are four principal routes through which a manufacturer may market a nonprescription drug product. Three of these routes apply to what are defined as 'new drugs'and require FDA's approval of a manufacturer's application to market a specific drug product. FDA's approval of any of the three types of new-drug application, referred to as 'NDAs,' indicates that the product has been determined safe and effective for its intended use and does not violate any other applicable regulations. (KAR)

Descriptors :   *DRUGS, *REGULATIONS, MANUFACTURING, MARKETING, VULNERABILITY, ADVERSE CONDITIONS, QUALITY ASSURANCE.

Subject Categories : Government and Political Science
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE