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FDA's Off-Label Data Dissemination Study Criteria Too Strict, HIMA Says

This article was originally published in The Gray Sheet

Executive Summary

Information derived from a peer-reviewed investigation published in a scientific or medical journal about a new or unapproved use of a medical device, drug or biologic should be considered "scientifically sound" and therefore eligible for dissemination by manufacturers, the Health Industry Manufacturers Association maintains in recent comments to FDA.

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