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Academic Journal

Novel drugs approved by the EMA, the FDA, and the MHRA in 2023: A year in review.

  • Authors : Papapetropoulos A; Laboratory of Pharmacology, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.; Clinical, Experimental Surgery and Translational Research Center, Biomedical Research Foundation of the Academy of Athens, Athens, Greece.

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

  • Source: British journal of pharmacology [Br J Pharmacol] 2024 Jun; Vol. 181 (11), pp. 1553-1575. Date of Electronic Publication: 2024 Mar 22.Publisher: Wiley Country of Publication: England NLM ID: 7502536 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1476-5381

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Academic Journal

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.

  • Authors : Davenport C; Radius Health, Inc., 22 Boston Wharf Road, 7th Floor, Boston, MA, 02210, USA. .; Gravel P

Subjects: Drug Approval* ; Osteoporosis*/Osteoporosis*/Osteoporosis*/drug therapy ; Parathyroid Hormone-Related Protein*

  • Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 May; Vol. 58 (3), pp. 505-518. Date of Electronic Publication: 2024 Feb 10.Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Withdrawing Approval of Makena - A Proposal from the FDA Center for Drug Evaluation and Research.

  • Authors : Chang CY; From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.; Nguyen CP

Subjects: Drug Approval* ; United States Food and Drug Administration*; 17 alpha-Hydroxyprogesterone Caproate/17 alpha-Hydroxyprogesterone Caproate/17 alpha-Hydroxyprogesterone Caproate/*therapeutic use

  • Source: The New England journal of medicine [N Engl J Med] 2020 Dec 10; Vol. 383 (24), pp. e131. Date of Electronic Publication: 2020 Nov 03.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562

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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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Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.

  • Authors : Khin NA; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.; Francis G

Subjects: Drug Approval* ; United States Food and Drug Administration*; Clinical Trials as Topic/Clinical Trials as Topic/Clinical Trials as Topic/*standards

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Nov; Vol. 108 (5), pp. 949-963. Date of Electronic Publication: 2020 Mar 28.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model:

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Academic Journal

Expert Panel Review to Compare FDA and EMA Guidance on Drug Development and Endpoints in Nonalcoholic Steatohepatitis.

Subjects: Clinical Trials as Topic/Clinical Trials as Topic/Clinical Trials as Topic/*standards ; Drug Development/Drug Development/Drug Development/*methods ; Drug Development/Drug Development/Drug Development/*organization & administration

  • Source: Gastroenterology [Gastroenterology] 2022 Mar; Vol. 162 (3), pp. 680-688. Date of Electronic Publication: 2021 Nov 23.Publisher: W.B. Saunders Country of Publication: United States NLM ID: 0374630 Publication Model:

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Academic Journal

Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.

  • Authors : Vreman RA; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; National Health Care Institute, Diemen, The Netherlands.

Subjects: Decision Making* ; Drug Approval* ; Technology Assessment, Biomedical*

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Aug; Vol. 108 (2), pp. 350-357. Date of Electronic Publication: 2020 Apr 20.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model:

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Academic Journal

Non-FDA-Reviewed Imported European Formula Use Among Parents in Urban Pediatric Private Practice.

Subjects: Parents* ; Private Practice* ; United States Food and Drug Administration*

  • Source: Clinical pediatrics [Clin Pediatr (Phila)] 2020 Jun; Vol. 59 (6), pp. 566-572. Date of Electronic Publication: 2020 Mar 07.Publisher: Sage Publications Country of Publication: United States NLM ID: 0372606 Publication Model:

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Academic Journal

Communicating emerging risks of SGLT2 inhibitors-timeliness and transparency of medicine regulators.

  • Authors : Bhasale A; University of Sydney Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, 6W75, The Hub, Charles Perkins Centre D17, University of Sydney, NSW 2006, Australia .; Mintzes B

Subjects: Communication* ; Drug-Related Side Effects and Adverse Reactions* ; Risk*

  • Source: BMJ (Clinical research ed.) [BMJ] 2020 Apr 29; Vol. 369, pp. m1107. Date of Electronic Publication: 2020 Apr 29.Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN:

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  • 1-10 of  157,630 results for ""United States""