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Latest Center for Devices and Radiological Health Stories

2011-08-22 10:00:00

Kinexum Will Provide Strategic Services to Facilitate Overseas Expansion and Advancement of Regulatory and Commercial Goals for Korea Health Industry Development Dr. Ronda Balham Joins Kinexum As Senior Partner, Medical Device Practice (PRWEB) August 22, 2011 Kinexum has been invited by RHI, a non-profit organization comprised of Group/Institutional members and industry and academic professionals having a deep and broad range of experience in international regulatory requirements to...

2011-08-17 07:47:00

Second melanoma drug approved this year that improves overall survival SILVER SPRING, Md., Aug. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Zelboraf is specifically indicated for the treatment of patients with...

2011-08-15 09:53:00

SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Released today, the guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are...

2011-08-15 09:30:00

SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Manufacturers submit PMA applications for high-risk (class III) medical devices. These applications undergo the most stringent type of FDA device review. PMA submissions include data...


Word of the Day
monteith
  • A large punch-bowl of the eighteenth century, usually of silver and with a movable rim, and decorated with flutings and a scalloped edge. It was also used for cooling and carrying wine-glasses.
  • A kind of cotton handkerchief having white spots on a colored ground, the spots being produced by a chemical which discharges the color.
This word is possibly named after Monteith (Monteigh), 'an eccentric 17th-century Scotsman who wore a cloak scalloped at the hem.'
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