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Last updated on April 24, 2014 at 13:19 EDT

Latest Center for Devices and Radiological Health Stories

2011-10-03 10:41:00

SILVER SPRING, Md., Oct. 3, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The report, "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital...

2011-09-30 10:02:00

Reflects FDA's commitment to work with industry to bring safe and effective products to market quickly SILVER SPRING, Md., Sept. 30, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet the requirements for clearance under the better-known 510(k) review process. (Logo:...

2011-09-26 13:15:00

SILVER SPRING, Md., Sept. 26, 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 September 26, 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...

2011-09-06 12:29:00

Training a key step to improving device review program, strategic priorities SILVER SPRING, Md., Sept. 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The Reviewer Certification...

2011-08-26 15:43:00

Second targeted therapy approved with a test this year SILVER SPRING, Md., Aug. 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Xalkori is being approved with a companion diagnostic test that...

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...