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The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
Nephrology (from Ancient Greek nephros 'kidney' and -logy 'the study of') is a specialty for both adult internal medicine and pediatric medicine that concerns the study of the kidneys, specifically normal kidney function (renal physiology) and kidney disease (renal pathophysiology), the preservation of kidney health, and the treatment of kidney disease, from diet and medication to renal ...
The European Medical Association (EMA) was established by doctors from the 12 member states in 1990 in Belgium, [1] EMA is the main association representing Medical Doctors in Europe, supporting the European Commission - Lifelong Learning Programme (LLP).
Burton Rose was a clinical professor of medicine at Harvard University. [3] He also held positions at the University of Massachusetts Medical School, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center. [2]
From that starting point, the European Society of Pediatric Nephrology emerged, followed by the American Society of Pediatric Nephrology in 1967. [7] The first meeting of the IPNA was held in 1968 in Guadalajara, Mexico, under the leadership of Gustavo Gordillo. Thus, the first international collaboration of specialists caring for children with ...
Nature Reviews Nephrology is a monthly peer-reviewed review journal published by Nature Portfolio. It was established as Nature Clinical Practice Nephrology in 2005, but change name in 2009. [ 1 ] [ 2 ] [ 3 ] The editor-in-chief is Susan Allison.
In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of ...