Microbicides from a regulatory perspective

  • Stone A
  • Harrison P
  • Lusti-Narasimhan M
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Abstract

OBJECTIVE: To provide researchers, product sponsors, drug regulators, and funding organizations with a convenient reference regarding regulatory guidance for microbicide development and licensure.

METHODS: WHO and other leading agencies in the microbicide field sponsored a series of technical consultations over the past decade that engaged a wide range of international experts in regional settings of primary relevance for microbicide development, testing, and eventual use. This article summarizes the results of those consultations against the ever-changing background of HIV prevention.

RESULTS: These efforts have significantly clarified the scientific basis for developing regulatory guidance for microbicide development and licensure.

CONCLUSION: The technical consultations organised by WHO and others have substantially expanded regulatory perspectives about the development and testing of topical microbicides for preventing the sexual transmission of HIV and other STIs.

Author-supplied keywords

  • Clinical trials
  • HIV
  • Microbicides
  • Prevention
  • Regulation
  • Sexually transmitted infections

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Authors

  • Alan B. Stone

  • Polly F. Harrison

  • Manjula Lusti-Narasimhan

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