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REMS Audits: Legal and Practical Challenges

This article was originally published in RPM Report

Executive Summary

Biopharma companies have been vociferous in their objections to FDA's proposal that they audit other sectors of the health care system to determine the success of REMS once drugs get into commercial distribution. Audits would clearly be a large undertaking for biopharma companies. But even if they cannot cut off FDA's interest in an added audit function, the complaints may lead to a positive outcome: getting FDA on the side of more efforts by biopharma companies to track data on their products.

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