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Academic Journal

Synthetic Approaches to the New Drugs Approved During 2022.

  • Authors : France SP; Process Research and Development, Merck & Co., Rahway, NJ 07065, United States.; Lindsey EA

Subjects: Drug Approval*; United States ; Japan

  • Source: Journal of medicinal chemistry [J Med Chem] 2024 Mar 28; Vol. 67 (6), pp. 4376-4418. Date of Electronic Publication: 2024 Mar 15.Publisher: American Chemical Society Country of Publication: United States NLM ID: 9716531

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Academic Journal

Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan.

  • Authors : Ono M; Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Waseda University, 2-2 Wakamatsucho, Shinjuku, Tokyo, 162-8480, Japan.; Iwasaki K

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

  • Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jan; Vol. 57 (1), pp. 86-99. Date of Electronic Publication: 2022 Sep 07.Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century.

  • Authors : Miura E; Kobe, 650-8586, Japan. .

Subjects: International Cooperation*; United States ; Humans

  • Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jan; Vol. 58 (1), pp. 184-191. Date of Electronic Publication: 2023 Oct 27.Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium:

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Editorial & Opinion

Collateral damage from accelerated drug approval.

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; Acceleration*; United States

  • Source: Nature [Nature] 2023 Oct; Vol. 622 (7982), pp. 242.Publisher: Nature Publishing Group Country of Publication: England NLM ID: 0410462 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline.

  • Authors : Iwamoto K; Department of Psychiatry, Graduate School of Medicine, Nagoya University, Nagoya, Japan.; Nakabayashi T

Subjects: Psychotropic Drugs*/Psychotropic Drugs*/Psychotropic Drugs*/adverse effects ; Motor Vehicles*; United States

  • Source: Neuropsychopharmacology reports [Neuropsychopharmacol Rep] 2023 Jun; Vol. 43 (2), pp. 172-176. Date of Electronic Publication: 2023 Apr 14.Publisher: John Wiley & Sons, Inc Country of Publication: United States NLM ID: 101719700 Publication

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Academic Journal

Orphan medical devices have come a long way.

  • Authors : Dooms M; IRDiRC Working Group on MedTech for Rare Diseases, University Hospitals Leuven, Leuven, Belgium. .

Subjects: Orphan Drug Production* ; Rare Diseases*/Rare Diseases*/Rare Diseases*/drug therapy; Infant, Newborn

  • Source: Orphanet journal of rare diseases [Orphanet J Rare Dis] 2023 Apr 05; Vol. 18 (1), pp. 71. Date of Electronic Publication: 2023 Apr 05.Publisher: BioMed Central Country of Publication: England NLM ID: 101266602 Publication Model: Electronic Cited Medium: Internet ISSN: 1750-1172

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Academic Journal

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.

  • Authors : Bennett CL; College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence; Antineoplastic Agents, Immunological/Antineoplastic Agents, Immunological/Antineoplastic Agents, Immunological/*therapeutic use

  • Source: The Lancet. Oncology [Lancet Oncol] 2020 Dec; Vol. 21 (12), pp. e575-e588.Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print Cited Medium: Internet ISSN: 1474-5488

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Academic Journal

Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union.

  • Authors : Hirota S; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.; Yamaguchi T

Subjects: Drug Approval* ; Drug Labeling* ; Off-Label Use*

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Nov; Vol. 108 (5), pp. 985-994. Date of Electronic Publication: 2020 Jan 25.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model:

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Academic Journal

Comparison of Addition of Indications for Antineoplastic Agents Approved in the United States and Japan from 2001 to 2020.

  • Authors : Shizuya T; Division of Social Pharmacy and Regulatory Science, Showa Pharmaceutical University.; Japan Development, MSD K.K.

Subjects: Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/therapeutic use ; Neoplasms*/Neoplasms*/Neoplasms*/drug therapy; Humans

  • Source: Biological & pharmaceutical bulletin [Biol Pharm Bull] 2023; Vol. 46 (7), pp. 987-996.Publisher: Pharmaceutical Society of Japan Country of Publication: Japan NLM ID: 9311984 Publication

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Academic Journal

International Harmonization for Cell and Gene Therapy Products.

  • Authors : Arcidiacono J; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA. .

Subjects: International Cooperation* ; Genetic Therapy*; Humans

  • Source: Advances in experimental medicine and biology [Adv Exp Med Biol] 2023; Vol. 1430, pp. 235-240.Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 0121103

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  • 1-10 of  8,790 results for ""United States. Food and Drug Administration""