Results 31 to 40 of about 4,926,176 (337)
JAMA Internal Medicine, 2021 Key Points Question Are cancer drugs granted accelerated approval from the US Food and Drug Administration (FDA) recommended for funding through the National Health Service (NHS) in England?
Avi Cherla +4 more
semanticscholar +1 more source
Pragmatic clinical trials in the context of regulation of medicines
Upsala Journal of Medical Sciences, 2019 The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data.
Rolf Gedeborg +3 more
doaj +1 more source
The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?
Cancer Management and Research, 2021 Michael Patrick Lux, 1 Oriana Ciani, 2 William CN Dunlop, 3 Andrea Ferris, 4 Michael Friedlander 5 1Department of Gynecology and Obstetrics, Frauenklinik St. Louise Paderborn, St. Josefs-Krankenhaus Salzkotten, Frauen- und Kinderklinik St.
Lux MP +4 more
doaj
Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics
JACC: Basic to Translational Science, 2017 Eroom’s law (Moore’s law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades.
Gail A. Van Norman, MD
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Central Asian Journal of Medical Hypotheses and Ethics, 2023 ACTH is a pituitary hormone important for proper function of adrenal glands, cortisol production as well as human physiology in general. It is involved in the pathogenesis of several endocrine disorders like Cushing syndrome and can be a useful ...
George Iliopoulos, Dimitrios Daoussis
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Current landscape of clinical development and approval of advanced therapies
Molecular Therapy: Methods & Clinical Development, 2021 Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ...
Carolina Iglesias-Lopez +3 more
doaj +1 more source
Trends in FDA drug approvals over last 2 decades: An observational study
Journal of Family Medicine and Primary Care, 2020 Introduction: The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important ...
Angelika Batta +2 more
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Frontiers in Pharmacology, 2021 Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved
Carolina Iglesias-Lopez +5 more
doaj +1 more source
Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries
Revista Panamericana de Salud Pública, 2021 Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are ...
Carlos E. Durán +6 more
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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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