Results 21 to 30 of about 1,536,180 (350)
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
Drugs, Devices, and the FDA: Part 1
JACC: Basic to Translational Science, 2016 Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj +1 more source
The importance of greater speed in drug development for advanced malignancies
Cancer Medicine, 2018 It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life‐years potentially saved if selected agents were ...
David J. Stewart +9 more
doaj +1 more source
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
Urine Screening for Opiod and Illicit Drugs in the Total Joint Arthroplasty Population [PDF]
, 2020 Introduction. Recent studies have shown an increase in post-operative orthopaedic complications associated with pre-operative opioid use. It is, therefore, important to know if patients use opioids before scheduled surgery.
Bhargava, Tarun +6 more
core +2 more sources
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
Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]
, 2005 Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
core +2 more sources
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
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
New Drugs Approved in 2009 [PDF]
Baylor University Medical Center Proceedings, 2010 The article briefly reviews selected new drug entities approved by the Food and Drug Administration in 2009.
Sarah Brooks, Erin Sears
openaire +3 more sources