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  • leave_it_to_beaver1 leave_it_to_beaver1 Jun 2, 2009 7:05 PM Flag

    glass half full, maybe

    Great find, thank you!

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    • Thanks,
      I liked what was said here:
      Recommendations:

      If the FDA wants to restore confidence in the FDA, and restore the independence that FDA advisory committees were intended to provide, it is essential that the FDA make changes in the policies and process governing its advisory committees. The following recommendations are based on the assumption that the Congress and the FDA are committed to that end:


      2. The FDA should provide explicit and specific oral guidance whenever needed during advisory committee meetings regarding appropriate criteria for safety and effectiveness, and appropriate criteria for conditions of approval.

      Given the past history the FDA should have provided explicit and specific oral guidance to the advisory committee meetings today regarding appropriate criteria for safety and effectiveness, and appropriate criteria for conditions of approval. I believe this did not happen.