Results 21 to 30 of about 931,067 (298)
Overview of drugs approved by the FDA in 2022
Фармация и фармакология (Пятигорск), 2023 The aim of the work is to conduct a review of medications approved by the FDA in 2022.Materials and methods. In searching for the materials to write this review article, bibliographic databases including PubMed, Google Scholar and e-library.ru were ...
D. V. Kurkin +14 more
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Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]
, 2013 This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
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A review of new drugs approved by the food and drug administration in 2022
Journal of Family Medicine and Primary Care, 2023 Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan +2 more
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US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis [PDF]
, 2019 IMPORTANCE The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.OBJECTIVES To determine how often ...
Chalmers, Iain +5 more
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Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Frontiers in Medicine, 2017 Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s ...
Marc Kusinitz +2 more
doaj +1 more source
Nature Communications, 2021 SARS-CoV2 infection has been linked to a wide range of clinical severities and the immunopathology is still under intense scrutiny. Here, the authors uncover an association of antibody affinity maturation and plasma IgA levels with clinical outcome in ...
Juanjie Tang +8 more
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Identification of New Drug Candidates Against \u3cem\u3eBorrelia burgdorferi\u3c/em\u3e Using High-Throughput Screening [PDF]
, 2016 Lyme disease is the most common zoonotic bacterial disease in North America. It is estimated that .300,000 cases per annum are reported in USA alone. A total of 10%–20% of patients who have been treated with antibiotic therapy report the recrudescence of
Babar, Mustafeez Mujtaba +9 more
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Реальная клиническая практика: данные и доказательства, 2023 In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
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Analysing musical performance through functional data analysis: rhythmic structure in Schumann's Träumerei [PDF]
, 2009 Functional data analysis (FDA) is a relatively new branch of statistics devoted to describing and modelling data that are complete functions. Many relevant aspects of musical performance and perception can be understood and quantified as dynamic ...
Almansa, J +1 more
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