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Enforce FD&C Act; Don't Stretch It

This article was originally published in RPM Report

Executive Summary

The new FDA senior leadership duo of Hamburg and Sharfstein are sending signs that they are ready to find some object lessons for high-visibility enforcement actions. A former FDA chief counsel and Just Department chief of staff warn that the agency should pict its targets carefully. Enforcing regulatory priorities instead of regulatory law can get the agency into difficult situations.

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