What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?

By Rachel Sachs Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here […]

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Introducing New Blogger Aaron S. Kesselheim

Aaron S. Kesselheim, M.D., J.D., M.P.H. [Twitter: @akesselheim], is an Associate Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). Within the Division, Aaron leads the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research], an […]

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House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement

By Rachel Sachs The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. […]

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