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Akademický článek

FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

Autor: Warraich HJ; US Food and Drug Administration, Silver Spring, Maryland., Tazbaz T; US Food and Drug Administration, Silver Spring, Maryland., Califf RM; US Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: JAMA [JAMA] 2024 Oct 15. Date of Electronic Publication: 2024 Oct 15.

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Editorial & Opinion

Opportunities for Innovation in Smoking Cessation Therapies: A Perspective From the National Institutes of Health and U.S. Food and Drug Administration.

Autor: Warraich HJ; U.S. Food and Drug Administration, Silver Spring, Maryland (H.J.W., B.A.K., M.T.H., R.M.C.)., King BA; U.S. Food and Drug Administration, Silver Spring, Maryland (H.J.W., B.A.K., M.T.H., R.M.C.)., Compton WM; National Institutes of Health, Bethesda, Maryland (W.M.C., E.S.H., M.M.B.)., Herrmann ES; National Institutes of Health, Bethesda, Maryland (W.M.C., E.S.H., M.M.B.)., Hai MT; U.S. Food and Drug Administration, Silver Spring, Maryland (H.J.W., B.A.K., M.T.H., R.M.C.)., Califf RM; U.S. Food and Drug Administration, Silver Spring, Maryland (H.J.W., B.A.K., M.T.H., R.M.C.)., Bertagnolli MM; National Institutes of Health, Bethesda, Maryland (W.M.C., E.S.H., M.M.B.).

Publikováno v: Annals of internal medicine [Ann Intern Med] 2024 Oct 15. Date of Electronic Publication: 2024 Oct 15.

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Akademický článek

The role of FDA advisory committees.

Autor: Helms Williams EC; US Food and Drug Administration, Silver Spring, Maryland, USA. emily.helmswilliams@fda.hhs.gov., Bumpus NN; US Food and Drug Administration, Silver Spring, Maryland, USA., Califf RM; US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Nature medicine [Nat Med] 2024 Sep 30. Date of Electronic Publication: 2024 Sep 30.

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Akademický článek

Post-approval evidence generation: a shared responsibility for healthcare.

Autor: Abbasi A; US Food and Drug Administration, Silver Spring, Maryland, USA., Rivera D; US Food and Drug Administration, Silver Spring, Maryland, USA., Curtis LH; US Food and Drug Administration, Silver Spring, Maryland, USA., Califf RM; US Food and Drug Administration, Silver Spring, Maryland, USA. commissioner@fda.hhs.gov.

Publikováno v: Nature medicine [Nat Med] 2024 Sep 13. Date of Electronic Publication: 2024 Sep 13.

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Akademický článek

Why Evidence Generation Should Matter to Payers and How They Can Help.

Autor: Abbasi AB; US Food and Drug Administration, Silver Spring, Maryland., Curtis LH; US Food and Drug Administration, Silver Spring, Maryland., Fleisher LA; University of Pennsylvania, Philadelphia., Califf RM; US Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: JAMA [JAMA] 2024 Aug 06; Vol. 332 (5), pp. 412-417.

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Akademický článek

Why Should the FDA Focus on Pragmatic Clinical Research?

Autor: Abbasi AB; US Food and Drug Administration, White Oak Campus, Silver Spring, Maryland., Curtis LH; US Food and Drug Administration, White Oak Campus, Silver Spring, Maryland., Califf RM; US Food and Drug Administration, White Oak Campus, Silver Spring, Maryland.

Publikováno v: JAMA [JAMA] 2024 Jul 09; Vol. 332 (2), pp. 103-104.

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Akademický článek

The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided.

Autor: Angus DC; JAMA , Chicago, Illinois.; University of Pittsburgh Schools of the Health Sciences, Pittsburgh, Pennsylvania., Huang AJ; University of California, San Francisco., Lewis RJ; JAMA , Chicago, Illinois.; David Geffen School of Medicine at UCLA, Los Angeles, California., Abernethy AP; Verily Life Sciences, San Francisco, California.; Now with Highlander Health, Dallas, Texas., Califf RM; US Food and Drug Administration, Washington, DC., Landray M; Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.; Protas, Manchester, United Kingdom., Kass N; Johns Hopkins University, Baltimore, Maryland., Bibbins-Domingo K; JAMA , Chicago, Illinois.; University of California, San Francisco.

Publikováno v: JAMA [JAMA] 2024 Jul 09; Vol. 332 (2), pp. 153-162.

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Akademický článek

The FDA and the Cardiovascular Community.

Autor: Warraich HJ; U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Electronic address: haider.warraich@fda.hhs.gov., Califf RM; U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Journal of the American College of Cardiology [J Am Coll Cardiol] 2024 Jul 02; Vol. 84 (1), pp. 124-129.

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