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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]
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 ...
The office's primary duty is the implementation of 45 CFR 46, a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection ...
The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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
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 ...
Cell culture vials The University of Florida Cancer and Genetics Research Complex is an integrated medical research facility.. Medical research (or biomedical research), also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
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