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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Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.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SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.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...

2011-08-08 13:48:00

SILVER SPRING, Md., Aug. 8, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of August 8, 2011. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Events and Speeches for the...

2011-07-29 08:56:00

CDRH, IOM Committee Members, Industry and Stakeholders to Discuss WASHINGTON, July 29, 2011 /PRNewswire-USNewswire/ --On the heels of the release of the highly anticipated Institute of Medicine (IOM) report, Public Health Effectiveness of the FDA 510(k) Clearance Process, The Food and Drug Law Institute (FDLI) is holding a "Dialogue" on the report August 4 in Washington, D.C. The half-day meeting, called "An FDLI Dialogue: A First Look at the IOM Study of the 510(k) Clearance Process,"...

2011-07-29 08:10:00

Agency continues to improve device review process SILVER SPRING, Md., July 29, 2011 /PRNewswire-USNewswire/ -- The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The FDA commissioned the report in September 2009. While none of the IOM's recommendations are...

2011-07-26 13:07:00

SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- Do you have questions about medical devices you use at home? There are many such devices, from ventilators to blood pressure monitors. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Learn more during a 30-minute webinar hosted by the Food and Drug Administration's Center for Devices and Radiological Health. An FDA expert will discuss how FDA plans to address the increased use of medical devices in the home and will...


Word of the Day
mundungus
  • A stinking tobacco.
  • Offal; waste animal product; organic matter unfit for consumption.
This word comes from the Spanish 'mondongo,' tripe, entrails.