Results 31 to 40 of about 5,628,754 (380)
Product Complexity and Strategic Alliance on Drug Approval
American Business Review, 2021 Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA)
Taoyong Su +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
doaj +1 more source
Journal of Pharmaceutical Policy and Practice, 2017 Background The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focuses on diseases common in those ...
Rumiko Shimazawa, Masayuki Ikeda
doaj +1 more source
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
doaj +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
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
doaj +1 more source
The challenges of access to innovative medicines with limited evidence in the European Union
Frontiers in Pharmacology, 2023 The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases.
Antonio Vallano +7 more
doaj +1 more source
JAMA Oncology, 2019 Importance To date, an empirical evaluation of the quality of control arms in randomized clinical trials (RCTs) leading to anticancer drug approvals by the US Food and Drug Administration (FDA) has not been undertaken.
Talal Hilal, M. Sonbol, V. Prasad
semanticscholar +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
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
doaj +1 more source