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Periodical

FDA Okays First Drug for Scarring From Fatty Liver Disease.

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: JAMA [JAMA] 2024 May 07; Vol. 331 (17), pp. 1439.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.

  • Authors : Liu ITT; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.; Kesselheim AS

Subjects: Drug Approval* ; United States Food and Drug Administration* ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/therapeutic use

  • Source: JAMA [JAMA] 2024 May 07; Vol. 331 (17), pp. 1471-1479.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Physicians and Specialties in the Veterans Health Administration's Community Care Network.

Subjects: United States Department of Veterans Affairs*/United States Department of Veterans Affairs*/United States Department of Veterans Affairs*/organization & administration; Humans ; United States

  • Source: JAMA network open [JAMA Netw Open] 2024 May 01; Vol. 7 (5), pp. e2410841. Date of Electronic Publication: 2024 May 01.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

The US Food and Drug Administration Dual Mandate for Rapid Drug Review and Equity.

  • Authors : Miksad RA; Boston Medical Center, Boston University, Boston, Massachusetts.; Ryals CA

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: JAMA network open [JAMA Netw Open] 2024 May 01; Vol. 7 (5), pp. e2411447. Date of Electronic Publication: 2024 May 01.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.

  • Authors : Mooghali M; Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut.

Subjects: Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/methods ; Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/statistics & numerical data ; Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/standards

  • Source: JAMA network open [JAMA Netw Open] 2024 May 01; Vol. 7 (5), pp. e249233. Date of Electronic Publication: 2024 May 01.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

The FDA in the Crosshairs-Science, Politics, and Abortion.

Subjects: Abortion, Induced*/Abortion, Induced*/Abortion, Induced*/legislation & jurisprudence ; Abortion, Induced*/Abortion, Induced*/Abortion, Induced*/methods ; Politics*

  • Source: JAMA [JAMA] 2024 Apr 16; Vol. 331 (15), pp. 1269-1270.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

State-Regulated Psychedelics on a Collision Course With FDA.

  • Authors : Marks M; Project on Psychedelics Law and Regulation (POPLAR), Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, Massachusetts.; Florida State University College of Law, Tallahassee.

Subjects: Hallucinogens*/Hallucinogens*/Hallucinogens*/pharmacology ; Hallucinogens*/Hallucinogens*/Hallucinogens*/therapeutic use ; State Government*

  • Source: JAMA [JAMA] 2023 Dec 26; Vol. 330 (24), pp. 2337-2338.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration-Regulated Products.

  • Authors : Tu SS; West Virginia University College of Law, Morgantown.; Leadmon C

Subjects: Patents as Topic*/Patents as Topic*/Patents as Topic*/ethics ; Patents as Topic*/Patents as Topic*/Patents as Topic*/legislation & jurisprudence ; Scientific Misconduct*/Scientific Misconduct*/Scientific Misconduct*/ethics

  • Source: JAMA [JAMA] 2023 Dec 05; Vol. 330 (21), pp. 2119-2121.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Case Sampling vs Universal Review for Evaluating Hospital Postoperative Mortality in US Surgical Quality Improvement Programs.

  • Authors : Chen VW; Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.; Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.

Subjects: Quality Improvement* ; United States Department of Veterans Affairs*; Male

  • Source: JAMA surgery [JAMA Surg] 2023 Dec 01; Vol. 158 (12), pp. 1312-1319.Publisher: American Medical Association Country of Publication: United States

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