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January 19, 1963


JAMA. 1963;183(3):17-18. doi:10.1001/jama.1963.03700030001001

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Drug Investigation Rules.  —The Food and Drug Administration issued new regulations which require detailed reporting to the government of clinical investigations of new drugs. The regulations become effective on Feb 7.The Pharmaceutical Manufacturers Association said in a statement that the agency obviously had reacted to resolve most of the difficulties presented by the new rules when they were first proposed last summer, but added that the burden of paper work on investigators still will be "enormous." The PMA said that the success of the new rules depends in large part on how they are administered and added that appropriate amendments may be needed in the near future.The new regulations require:

  • That the Food and Drug Administration be put on notice and given the full details about the distribution of drugs for investigational use.

  • That clinical investigations be based on adequate studies on animals to assure safety.

  • That the

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