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Language : english Publisher : american medical association Subject : drug approval Filter by : Subject
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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: Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/therapeutic use ; Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; Drug Approval*/Drug Approval*/Drug Approval*/methods

  • 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

Clinical Value of Molecular Targets and FDA-Approved Genome-Targeted Cancer Therapies.

  • Authors : Tibau A; Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.; Oncology Department, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, and Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain.

Subjects: Neoplasms*/Neoplasms*/Neoplasms*/drug therapy ; Neoplasms*/Neoplasms*/Neoplasms*/genetics ; United States Food and Drug Administration*

  • Source: JAMA oncology [JAMA Oncol] 2024 May 01; Vol. 10 (5), pp. 634-641.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

CMS Will Cover Alzheimer Drugs With Traditional FDA Approval.

Subjects: Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/drug therapy ; Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/economics ; Centers for Medicare and Medicaid Services, U.S.*/Centers for Medicare and Medicaid Services, U.S.*/Centers for Medicare and Medicaid Services, U.S.*/economics

  • Source: JAMA [JAMA] 2023 Jul 03; Vol. 330 (1), pp. 14.Publisher: American Medical Association Country of Publication: United States

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Periodical

FDA Okays First Drug for Scarring From Fatty Liver Disease.

Subjects: Drug Approval* ; Non-alcoholic Fatty Liver Disease*/Non-alcoholic Fatty Liver Disease*/Non-alcoholic Fatty Liver Disease*/drug therapy ; Non-alcoholic Fatty Liver Disease*/Non-alcoholic Fatty Liver Disease*/Non-alcoholic Fatty Liver Disease*/complications

  • 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

Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.

  • Authors : Wallach JD; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.

Subjects: Biomarkers*/Biomarkers*/Biomarkers*/analysis ; Chronic Disease*/Chronic Disease*/Chronic Disease*/drug therapy ; Drug Approval*/Drug Approval*/Drug Approval*/methods

  • Source: JAMA [JAMA] 2024 May 21; Vol. 331 (19), pp. 1646-1654.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.

  • Authors : Shahzad M; Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.; Naci H

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/methods ; United States Food and Drug Administration*; United States

  • Source: JAMA [JAMA] 2023 Mar 07; Vol. 329 (9), pp. 760-761.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Availability and Coverage of New Drugs in 6 High-Income Countries With Health Technology Assessment Bodies.

  • Authors : Wouters OJ; Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.; Naci H

Subjects: Technology Assessment, Biomedical* ; Drug Approval*; Humans

  • Source: JAMA internal medicine [JAMA Intern Med] 2024 Mar 01; Vol. 184 (3), pp. 328-330.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Innovation in Development of Dermatologic Drugs Approved by the US Food and Drug Administration Between 2012 and 2022.

  • Authors : Kamat S; Department of Medical Education, Icahn School of Medicine at Mount Sinai, New York, New York.; Ungar B

Subjects: Drug Approval*; United States ; Humans

  • Source: JAMA dermatology [JAMA Dermatol] 2024 Feb 01; Vol. 160 (2), pp. 226-229.Publisher: American Medical Association Country of Publication: United States

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Academic Journal

Concerns That May Limit the Utility of Zuranolone.

Subjects: Drug Approval* ; Antidepressive Agents*/Antidepressive Agents*/Antidepressive Agents*/therapeutic use; Pregnanes

  • Source: JAMA [JAMA] 2024 Jan 09; Vol. 331 (2), pp. 105-106.Publisher: American Medical Association Country of Publication: United States

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  • 1-10 of  747 results for ""UNITED States""