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Regulating in an Era of Increasingly Sophisticated Medicines – Striking the Balance Between Patient Benefits and Risks

This article was originally published in RPM Report

Executive Summary

Commissioner Hamburg’s April 22 keynote during the annual Rx Prescription Drug Abuse Summit in Atlanta, Georgia, came amid controversy over the agency’s decision to approve a long-acting hydrocodone formulation, Zohydro. Hamburg addressed the controversy head-on, but also delivered a lengthy and thorough outline of FDA’s intense work on the issue.

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