Search results
Results from the WOW.Com Content Network
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
The panel voted 10-to-1 against the first MDMA-based PTSD treatment, saying the benefits did not outweigh its risks, while nine members said the available data did not show its effectiveness in ...
The artificial sweetener aspartame has been the subject of several controversies since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. The FDA approval of aspartame was highly contested, beginning with suspicions of its involvement in brain cancer, [1] alleging that the quality of the initial research supporting its safety was inadequate and flawed, and that ...
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
(Reuters) - The U.S. FDA is ramping up its investigation of the clinical trials that tested an MDMA-based therapy, the Wall Street Journal reported on Friday, citing people familiar with the matter.
The initial approval was given for children aged between 4 and 5 years who can walk, based on a mid-stage trial, where the gene therapy produced a mini version of the dystrophin protein needed to ...
Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American [1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. [2]
In its discussion, the FDA had asked the panel to consider some unique aspects of Lilly's trial, which differed significantly from the trial design of Eisai and Biogen Leqembi, which won U.S ...