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Margaret Hamburg on the EMA at 20: An ever stronger bilateral partnership with the US FDA

This article was originally published in Scrip

Executive Summary

The partnership between the US Food and Drug Administration and the European Medicines Agency is rightly very strong, but now a broader, global regulatory approach is needed to ensure the safety and effectiveness of pharmaceutical products worldwide, says Margaret Hamburg, the outgoing commissioner of the US agency.

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Margaret Hamburg on the EMA at 20: An ever stronger bilateral partnership with the US FDA

The partnership between the US Food and Drug Administration and the European Medicines Agency is rightly very strong, but now a broader, global regulatory approach is needed to ensure the safety and effectiveness of pharmaceutical products worldwide, says Margaret Hamburg, the outgoing commissioner of the US agency.

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

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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