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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.
Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. [3] In addition, clinical research may require Institutional Review Board or Research Ethics Board and possibly other ...
Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- plasma derivatives, including immunoglobulins, hyperimmune products, and antitoxins. Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR) [2]
New Drug Application – a submission to the FDA by a pharmaceutical company for review and approval of a new drug Abbreviated New Drug Application – a submission to the FDA review and approval of a generic drug; FDA Fast Track Development Program – a designation given to an NDA by the FDA that accelerates review and approval of new drugs
An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
(Reuters) - Sarepta Therapeutics said on Friday that the US FDA would review an application seeking traditional approval for its gene therapy to treat a muscle-wasting disorder by June 21, months ...
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 ...
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 ...