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A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer says.
A recent event highlighting the 20th anniversary of the University of Pittsburgh Medical Center's (UPMC) artificial heart program focused on what implantable heart pumps have done to prolong patients' lives.
A new report says that many genomic tests currently used to diagnose and guide treatment of ovarian cancer have not been shown to decrease the number of deaths from the disease or improve patients' quality of life, HHS' Agency for Healthcare Research and Quality (AHRQ) said Oct. 16.
Firms should make safety research on nanoparticles a priority in their product design processes, because the FDA's limited resources do not allow the agency to fully research the potential safety risks of nanotechnology, experts say.
More than 20 leading pharmaceutical, medical device, and diagnostic companies, along with major academic brain research centers and patient advocacy groups, have joined to form a new trade association called the Neurotechnology Industry Organization (NIO).
PDL BioPharma, Inc. announced that in a research survey of U.S. cardiologists and emergency physicians, a considerable number (24%) were unaware of current heart attack treatment guidelines, with a majority (61%) believing that there is a significant opportunity to improve heart attack treatment in the U.S. by improving patient education about early heart attack symptoms and the need to expedite treatment to quickly restore blood flow to the heart.
Abbott Laboratories said Monday it agreed to supply Abbott Prism System automated blood screening instruments and assays to Blood Systems Laboratories through 2011.
Kinetic Concepts, Inc., a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces, announced that the U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for KCI's V.A.C. negative pressure wound therapy system.