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Alternative medicine approvals based on pilot efficacy trials urged by consultant.

This article was originally published in The Tan Sheet

Executive Summary

ALTERNATIVE MEDICINE PRODUCT APPROVAL BASED ON PILOT CLINICALS for efficacy and human safety trials was urged by Floyd Leaders, PhD, of The Leaders Group at a recent conference on alternative medicine in Arlington, Va. Leaders, who has served as a consultant to the National Institutes of Health's Office of Alternative Medicine, suggested that "FDA could grant marketing approval of an NDA for these products based on in-use human safety and pilot-level clinical trials for effectiveness."

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