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FDA: The Antidote to Anecdotal Safety Challenges

This article was originally published in RPM Report

Executive Summary

The Food & Drug Administration's role as the expert arbiter of drug safety issues is traditionally viewed as a threat to commercial products. But the agency also serves as an important protector of companies and products from unverified allegations of safety problems with marketed products or products in development. An important regional biotech trade group, BayBio, focuses on the role of FDA as impartial judge of the importance of clinical reports in a recent filing with the Supreme Court.

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