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Congress’ New Drug Safety Priority: FDA’s Authority Over Compounders

This article was originally published in RPM Report

Executive Summary

The meningitis outbreak caused by contaminated injectable steroids from a Massachusetts pharmacy is prompting lawmakers to pursue legislation that would clarify FDA’s authority over compounders. The challenge for FDA Commissioner Hamburg is convincing Congress to act, but not deliver an unfunded mandate. One thing is clear: it won’t be a quiet start to 2013 in biopharma legislation.

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