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PHASE I TRIAL INITIATION REQUIREMENTS ARE BEING DISCUSSED BY FDA

Executive Summary

PHASE I TRIAL INITIATION REQUIREMENTS ARE BEING DISCUSSED BY FDA and industry groups in a series of meetings concerning the differences between FDA's paperwork requirements and those outside the U.S. for beginning human clinical studies. The agency expects to finish dialogues with outside groups this summer and come up with recommendations on how FDA's procedures for allowing the start of Phase I studies might be streamlined to be more on par with procedures in Europe.
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PS024318

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