Results 41 to 50 of about 5,628,754 (380)
Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020 Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan +7 more
semanticscholar +1 more source
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
An analysis of common ethical justifications for compassionate use programs for experimental drugs [PDF]
, 2016 BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.
Raus, Kasper
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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
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
Children, 2022 Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric ...
Robert B. MacArthur +3 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
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
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
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.
Erin, Sears, Sarah, Brooks
openaire +2 more sources