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

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

Label
Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System
Title
Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System
Contributor
Subject
Language
eng
Summary
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)
Cataloging source
DTICE
Index
no index present
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
  • Chan, Kwai-Cheung
  • GENERAL ACCOUNTING OFFICE WASHINGTON DC PROGRAM EVALUATION AND METHODOLOGY DI V
http://library.link/vocab/subjectName
  • Drugs
  • Regulations
  • Manufacturing
  • Marketing
  • Vulnerability
  • Adverse conditions
  • Quality assurance
  • Government and Political Science
  • Pharmacology
Label
Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System
Instantiates
Publication
Note
Testimony before the Subcommittee on Regulation, Business Opportunities and Energy, Committee on Small Business, House of Representatives
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
6 pages
Form of item
online
Governing access note
APPROVED FOR PUBLIC RELEASE
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
System control number
  • (OCoLC)227823405
  • (OCoLC)ocn227823405
Label
Over The Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System
Publication
Note
Testimony before the Subcommittee on Regulation, Business Opportunities and Energy, Committee on Small Business, House of Representatives
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
6 pages
Form of item
online
Governing access note
APPROVED FOR PUBLIC RELEASE
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
System control number
  • (OCoLC)227823405
  • (OCoLC)ocn227823405

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