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The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. The answer lies in both an outdated way we develop prescription drugs and the continued quest for the next big blockbuster. In other words, money over safety.
In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. Actavis, 570 U.S. 136 (2013), [link] opinions/12pdf/12-416_m5n0.pdf.
Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S.
Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.
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