Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System,
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)
Document Details
- Document Type
- Technical Report
- Publication Date
- Apr 28, 1992
- Accession Number
- ADA290109
Entities
People
- Kwai-cheung Chan
Organizations
- United States Government Accountability Office