FDA Should Reduce Expensive Antibiotic Testing and Charge Fees Which More Closely Reflect Cost of Certification.

Abstract

The Food and Drug Administration (FDA) certifies batches of antibiotics, insulin, and color additives. Certification is the testing of batch samples for compliance with established standards and the issuing of certificates for batches that pass the tests. FDA charges fees to manufacturers to cover its cost of certification. The current level of antibiotic testing is not necessary. The number of batches failing certification tests has historically been low. Batch certification is an expensive product assurance strategy and other less costly control mechanisms are available. Further, GAO believes FDA should revise the method for determining the fees charged manufacturers for the cost of certification. GAO makes several recommendations to the Secretary of the Department of Health and Human Services to resolve these matters. (Author)

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Document Details

Document Type
Technical Report
Publication Date
Oct 28, 1981
Accession Number
ADA108434

Entities

Organizations

  • United States Government Accountability Office

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Accuracy
  • Administrative Personnel
  • Anti-Bacterial Agents
  • Business Administration
  • Dosage Forms
  • Financial Management
  • Laboratory Tests
  • Law
  • Management Personnel
  • Microbiological Tests
  • Monitoring
  • Performance Tests
  • Personnel Management
  • Quality Control
  • Standards
  • Test And Evaluation
  • Test Methods

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