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Academic Journal

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue-Based Products.

  • Authors : Dickson RP; Washtenaw County Tuberculosis Program, Ypsilanti, Michigan.; University of Michigan Medical School, Ann Arbor.

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

  • Source: JAMA [JAMA] 2024 May 28; Vol. 331 (20), pp. 1703-1704.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Academic Journal

Counterpoint: Why the FDA Should Not Regulate Laboratory-Developed Tests.

  • Authors : Leung ML; The Steve and Cindy Rasmussen Institute for Genomic Medicine, Nationwide Children's Hospital, Columbus, OH, United States.; Departments of Pathology and Pediatrics, The Ohio State University College of Medicine, Columbus, OH, United States.

Subjects: Clinical Laboratory Techniques*/Clinical Laboratory Techniques*/Clinical Laboratory Techniques*/standards ; Government Regulation* ; United States Food and Drug Administration*

  • Source: The journal of applied laboratory medicine [J Appl Lab Med] 2024 Jan 03; Vol. 9 (1), pp. 155-158.Publisher: Oxford University Press Country of Publication: England NLM ID: 101693884 Publication Model: Print Cited Medium: Print ISSN: 2576-9456

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Academic Journal

Point: The Need for Additional FDA Regulations in Laboratory Medicine.

  • Authors : Konnick EQ; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, United States.

Subjects: United States Food and Drug Administration* ; Clinical Laboratory Techniques*/Clinical Laboratory Techniques*/Clinical Laboratory Techniques*/standards ; Government Regulation*

  • Source: The journal of applied laboratory medicine [J Appl Lab Med] 2024 Jan 03; Vol. 9 (1), pp. 151-154.Publisher: Oxford University Press Country of Publication: England NLM ID: 101693884 Publication Model: Print Cited Medium: Print ISSN: 2576-9456

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Academic Journal

Navigating the FDA regulatory landscape.

  • Authors : Scott PD; Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Neurological and Physical Medicine Devices, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. .; Bajaj A

Subjects: Mental Disorders*/Mental Disorders*/Mental Disorders*/therapy ; United States Food and Drug Administration* ; Government Regulation*

  • Source: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology [Neuropsychopharmacology] 2024 Jan; Vol. 49 (1), pp. 18-22. Date of Electronic Publisher: Nature Publishing Group Country of Publication: England NLM ID: 8904907 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Eroding Judicial Deference to the FDA - Consequences for Public Health.

  • Authors : Daval CJR; From the 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.; Bendicksen L

Subjects: Government Regulation* ; Public Health*/Public Health*/Public Health*/legislation & jurisprudence ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence

  • Source: The New England journal of medicine [N Engl J Med] 2023 Mar 16; Vol. 388 (11), pp. 963-966. Date of Electronic Publication: 2023 Mar 11.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562

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Academic Journal

Mifepristone and the courts: The thread that could unravel regulation of drugs in the United States.

Subjects: Mifepristone* ; Government Regulation*; United States

  • Source: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2023 Sep; Vol. 32 (9), pp. 1049-1051. Date of ElectronicPublisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-1557

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Academic Journal

Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.

Subjects: Government Regulation* ; United States Food and Drug Administration*; Device Approval/Device Approval/Device Approval/*legislation & jurisprudence

  • Source: American journal of law & medicine [Am J Law Med] 2021 Jul; Vol. 47 (2-3), pp. 291-326.Publisher: Cambridge University Press Country of Publication: England NLM ID: 7509572 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

The US Regulatory System and COVID-19 Vaccines: The Importance of a Strong and Capable FDA.

  • Authors : Sharfstein JM; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.; Goodman JL

Subjects: COVID-19 Vaccines* ; Government Regulation* ; United States Food and Drug Administration*

  • Source: JAMA [JAMA] 2021 Mar 23; Vol. 325 (12), pp. 1153-1154.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Academic Journal

The FDA's Experience with Covid-19 Antibody Tests.

  • Authors : Shuren J; From the Food and Drug Administration, Silver Spring, MD.; Stenzel T

Subjects: Diagnostic Test Approval*/Diagnostic Test Approval*/Diagnostic Test Approval*/legislation & jurisprudence ; Government Regulation* ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/organization & administration

  • Source: The New England journal of medicine [N Engl J Med] 2021 Feb 18; Vol. 384 (7), pp. 592-594. Date of Electronic Publication: 2021 Feb 13.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562

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Academic Journal

Addressing health disparities in the Food and Drug Administration's artificial intelligence and machine learning regulatory framework.

  • Authors : Ferryman K; Tandon School of Engineering, New York University, Brooklyn, New York, USA.

Subjects: Government Regulation* ; Health Status Disparities* ; United States Food and Drug Administration*

  • Source: Journal of the American Medical Informatics Association : JAMIA [J Am Med Inform Assoc] 2020 Dec 09; Vol. 27 (12), pp. 2016-2019.Publisher: Oxford University Press Country of Publication: England NLM ID: 9430800 Publication Model: Print Cited Medium: Internet ISSN:

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  • 1-10 of  13,338 results for ""United States Food and Drug Administration""