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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. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.
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 United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.
(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 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 ...
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 ...