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In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). Former leaders of CDRH [15] Jeffrey Shuren, M.D., J.D., CDRH Director 2009 – 2024; Daniel Schultz M.D., CDRH Director 2004 – 2009
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
A study of radiation-induced skin injuries was performed in 1994 by the U.S. Food and Drug Administration (FDA) [58] [59] followed by an advisory to minimize further fluoroscopy-induced injuries. [60] The problem of radiation injuries due to fluoroscopy has been further addressed in review articles in 2000 [61] and 2010. [62]
Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR) [2] Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels. Vaccines for use in humans. Diagnostic and therapeutic allergenic extracts.
Two forms of radiographic images are in use in medical imaging. Projection radiography and fluoroscopy, with the latter being useful for catheter guidance. These 2D techniques are still in wide use despite the advance of 3D tomography due to the low cost, high resolution, and depending on the application, lower radiation dosages with 2D technique.
(Reuters) -The U.S. health regulator on Wednesday approved CorMedix's antimicrobial drug for reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, allowing ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
Charles River Laboratories International, Inc. is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the pharmaceutical, medical device and biotechnology industries. [2]