Tag: Postmarket studies

Postmarket studies

Regulatory/FDA

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]

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Regulatory/FDA

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

May 6, 2019 — “It doesn’t just take a village, it takes an ecosystem,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), told the annual meeting of the Reagan-Udall Foundation for the FDA in Washington on May 2, highlighting the challenge of drawing upon a sufficiently broad range of […]

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