Policy developments in regulatory approval

  title={Policy developments in regulatory approval},
  author={Robert J. Temple},
  journal={Statistics in Medicine},
  • R. Temple
  • Published 15 October 2002
  • Medicine
  • Statistics in Medicine
Although radical changes in drug regulation are rare (e.g., the Federal Food, Drug and Cosmetic Act of 1938 and the 1962 amendment to the Act creating an effectiveness requirement), regulations and guidance do evolve significantly in the face of new problems and accumulating experience. Recent changes have been driven by the Food and Drug Administration Modernization Act (FDAMA), user fee legislation, the International Conference on Harmonization, recent safety related drug withdrawals, and… 
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  • R. Temple
  • Medicine
    Accountability in research
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