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FDA military informed consent rule back to drawing board

Executive Summary

FDA withdraws its final rule on determining the circumstances under which informed consent can be waived for troops being given investigational drugs in combat situations. The rule would finalize a 1999 1interim final rule, which specifies that the President, and not the FDA commissioner, can make the determination (2"The Pink Sheet" Nov. 29, 1999, p. 10). FDA pulled the rule Oct. 10 after submitting it to OMB July 21...

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