Researchers warn faster pre-approval testing will increase reliance on weak postmarket oversight
1 Sep 18 5:00 AM · 5d ago · 5 articles · 1 post · 2 sources · development 1 of 1
Medical researchers warn that Trump administration policies reducing pre-approval testing will put more pressure on the postmarket system, which is already plagued by delays and enforcement failures. The shift risks exposing patients to drugs that may cause more harm than benefit.
“Reducing pre-approval testing "will inevitably put a lot of pressure on the post-approval system,"”
Aaron Kesselheim, professor of medicine, Harvard Medical SchoolSanket Dhruva Cardiologist and medicine professor, UC San FranciscoAaron Kesselheim Medicine professor, Harvard Medical SchoolFDA Regulator approving drugs and setting postmarket study requirementsDepartment of Health and Human Services Federal agency overseeing FDA
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Reported in the same hours no headline names this development itself — these 1 claim were published in its stretch
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5 outlets The FDA requires follow-up studies for drugs and devices. Years later, many still aren’t done
first by GovExec, 5d ago · also Orlando Sentinel, Mercury News, Baltimore Sun, KFF Health News
1 more headline
- The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done Orlando Sentinel · 19h ago
What people said 1 voice · verbatim
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"Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through. A KFF Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still…
All 1 developments of KFF analysis: Hundreds of FDA-ordered postmarket drug… →
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