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Academic Journal

Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information.

  • Authors : Dijk SW; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.

Subjects: Drug Approval* ; SARS-CoV-2* ; COVID-19*/COVID-19*/COVID-19*/epidemiology

  • Source: Medical decision making : an international journal of the Society for Medical Decision Making [Med Decis Making] 2024 Jul; Vol. 44 (5), pp. 512-528. Date of Electronic Publication: Publisher: Sage Publications Country of Publication: United States NLM ID: 8109073 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Access and Safety-The FDA Drug Approval Conundrum.

  • Authors : Good CB; UPMC Health Plan, Insurance Services Division, University of Pittsburgh, Pittsburgh, Pennsylvania.; Peasah SK

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

  • Source: JAMA network open [JAMA Netw Open] 2024 Jul 01; Vol. 7 (7), pp. e2419823. Date of Electronic Publication: 2024 Jul 01.Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet

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Academic Journal

Drug Approval for the Treatment of Geographic Atrophy: How We Got Here and Where We Need to Go.

  • Authors : Csaky KG; From the Retina Foundation of the Southwest (K.G.C.), Dallas, Texas, USA. Electronic address: .; Miller JML

Subjects: Geographic Atrophy*/Geographic Atrophy*/Geographic Atrophy*/drug therapy ; Geographic Atrophy*/Geographic Atrophy*/Geographic Atrophy*/physiopathology ; Drug Approval*

  • Source: American journal of ophthalmology [Am J Ophthalmol] 2024 Jul; Vol. 263, pp. 231-239. Date of Electronic Publication: 2024 Feb 21.Publisher: Elsevier Science Country of Publication: United States NLM ID: 0370500 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Editorial & Opinion

Regulation of Ophthalmic Ocular Hypotensive Drug Approval in the United States Over the Past 140 Years.

  • Authors : Novack GD; From the Department of Ophthalmology & Vision Sciences, University of California, Davis, Davis, California, USA; PharmaLogic Development, Inc., San Rafael, California, USA. Electronic address: .

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

  • Source: American journal of ophthalmology [Am J Ophthalmol] 2024 Jun; Vol. 262, pp. A1-A3. Date of Electronic Publication: 2024 Feb 27.Publisher: Elsevier Science Country of Publication: United States NLM ID: 0370500 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis.

  • Authors : Zosso-Pavic M; Division Clinical Assessment, Authorisation Sector, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland. Electronic address: .; Li Q

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; United States Food and Drug Administration*; Humans

  • Source: The Lancet. Oncology [Lancet Oncol] 2024 Jun; Vol. 25 (6), pp. 770-778. Date of Electronic Publication: 2024 May 13.Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia.

  • Authors : Chow WL; Pfizer (Malaysia) Sdn Bhd, Level 10 & 11, Wisma Averis (Tower 2), Bangsar South, No. 8, Jalan Kerinchi, 59200, Kuala Lumpur, Malaysia.; Salleh NAM

Subjects: Drug Approval* ; Health Services Accessibility*; Malaysia

  • Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 May; Vol. 58 (3), pp. 528-538. Date of Electronic Publication: 2024 Feb 20.Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

The evolutionary safety of mutagenic drugs should be assessed before drug approval.

  • Authors : Lobinska G; Department of Molecular Genetics, Weizmann Institute of Science, Rehovot, Israel.; Tretyachenko V

Subjects: Drug Approval* ; Mutagens*/Mutagens*/Mutagens*/toxicity; Mutagenesis

  • Source: PLoS biology [PLoS Biol] 2024 Mar 15; Vol. 22 (3), pp. e3002570. Date of Electronic Publication: 2024 Mar 15 (Print Publication: 2024).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101183755 Publication Model: eCollection Cited Medium: Internet

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Report

Critical insights into the evolving drug-approval process in China.

  • Authors : Nikanjam M; Division of Hematology-Oncology, University of California San Diego, La Jolla, California, USA.; Kurzrock R

Subjects: Drug Approval*; Humans ; United States

  • Source: Cancer [Cancer] 2024 Mar 01; Vol. 130 (5), pp. 665-667. Date of Electronic Publication: 2024 Jan 02.Publisher: Wiley Country of Publication: United States NLM ID: 0374236 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0142

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Periodical

COLD COMFORT.

Subjects: FREEDOM of Information Act (U.S.); DRUG approval

  • Source: Scientific American. Mar2024, Vol. 330 Issue 3, p64-69. 6p. 2 Color Photographs, 1 Diagram.

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Academic Journal

Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective.

  • Authors : Matsuda K; Department of Hematology and Oncology, JR Tokyo General Hospital, Shibuya-ku, Japan.; Nagai S

Subjects: Drug Approval* ; Hematologic Neoplasms*/Hematologic Neoplasms*/Hematologic Neoplasms*/drug therapy; Humans

  • Source: Japanese journal of clinical oncology [Jpn J Clin Oncol] 2023 Dec 07; Vol. 53 (12), pp. 1125-1129.Publisher: Oxford University Press Country of Publication: England NLM ID: 0313225 Publication Model: Print Cited Medium: Internet ISSN:

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  • 1-10 of  374,179 results for ""Drug Approval""