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Journal Cover The Gray Sheet
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [16 journals]
  • Photos Snapped During FDA Device Inspections: Fair Game Or Agency
           Overreach'
    • Abstract: FDA says it has the authority to take photographs during facility inspections, citing decades-old non-medical-device-related legal cases as evidence – including Dow Chemical Co. v. US – but industry lawyer Robert Klepinski says FDA's reliance on the Dow case as a defense for snapping pictures doesn't pass muster. "The agency always cites the Dow Chemical case, wherein the EPA flew over Dow's plant with a helicopter or airplane and took pictures," Klepinski said, noting that "it’s absolutely ludicrous, a stupid case to cite" because FDA investigators don't inspect device firms from the air.
      PubDate: Tue, 09 Feb 2016 11:00:00 -050
       
  • Warning Letter Roundup & Recap – February 9, 2016
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Tue, 09 Feb 2016 10:40:01 -050
       
  • FDA Lays Out Requirements For Diagnostic Radiology Display 510(k)s
    • Abstract: The draft guidance, which will replace a 2008 document, details FDA expectations for device descriptions and bench testing, including where they differ for mammography and non-mammography products.
      PubDate: Mon, 08 Feb 2016 18:15:19 -050
       
  • FDA Clears Validation Testing For Automated Endoscope Reprocessors
    • Abstract: FDA has found that validation test data for three automated endoscope reprocessors – including Medivators’ Advantage Plus and DSD Edge, and Steris’ System 1E Liquid Chemical Sterilant Processing System – are adequate.
      PubDate: Mon, 08 Feb 2016 18:15:02 -050
       
  • Boston Sci's Watchman Gets Positive Medicare Coverage
           Policy
    • Abstract: CMS granted national coverage for left atrial appendage closure procedures to prevent stroke under more favorable conditions than what the Medicare agency had proposed in November. This is good news for Boston Scientific, which is ramping up marketing of its Watchman device.
      PubDate: Mon, 08 Feb 2016 18:10:01 -050
       
  • Device Week – February 8, 2016
    • Abstract: On this week's podcast, "Gray Sheet" reporters and editors discuss a series of FDA human factors policy documents released for device and combination products, the ongoing independent assessment of CDRH, Zika virus diagnostics development and Capitol Hill updates.
      PubDate: Mon, 08 Feb 2016 00:02:56 -050
       
  • FDA Guidance Sheds Light On Human Factor Studies For Combo Products
    • Abstract: Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.
      PubDate: Fri, 05 Feb 2016 17:20:09 -050
       
  • Sen. Murray Prods FDA To Clarify 510(k) Modification Policies In Superbug
           Bill
    • Abstract: Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.
      PubDate: Fri, 05 Feb 2016 16:55:08 -050
       
  • People Briefs
    • Abstract: Stryker CFO retires and Osiris Therapeutics CEO resigns, as SpineGuard and Tandem Diabetes Care expand management teams.
      PubDate: Thu, 04 Feb 2016 18:00:11 -050
       
  • Stryker-Zimmer Case Sets Up Tech Industry, Government Clash On Patent
           Damages Issue
    • Abstract: In a case going before the Supreme Court in less than three weeks, Stryker is asking the court to broaden the circumstances under which patent damages may be tripled, a position the Obama administration appears to support but one that is getting pushback from tech firms, and at least one device-maker, Medtronic.
      PubDate: Thu, 04 Feb 2016 18:00:00 -050
       
  • Commercial, Academic Researchers Race To Develop Zika Tests
    • Abstract: Academic researchers supported by National Institutes of Health grants and several commercial diagnostic firms say they have already developed, or have almost completed work on, new Zika virus diagnostics. Meanwhile, congressional leaders are pressing HHS to expedite response efforts.
      PubDate: Wed, 03 Feb 2016 22:00:00 -050
       
  • Booz Allen: Too Soon To Say If FDA Process Reforms Are Working
    • Abstract: FDA's device center has implemented all the recommendations Booz Allen Hamilton has made in the past several years to improve the review process, the consulting firm said in its latest independent assessment report. But it is still too early to conclude if the changes have led to significant improvements.
      PubDate: Wed, 03 Feb 2016 21:50:02 -050
       
  • Store Clerk Prosecution Underscores FD&C Violation Risks For
           Individuals
    • Abstract: A store clerk accused of selling misbranded synthetic drugs was sentenced on misdemeanor violations of the Act. An appeals court verdict upholding the conviction could give FDA more latitude to pursue individuals responsible for violations in the drug and device space, attorneys say.
      PubDate: Wed, 03 Feb 2016 16:00:00 -050
       
  • Surgeons Slowed Use of Pelvic Mesh Following FDA Warning, N.Y. Study Shows
    • Abstract: Use of surgical mesh for pelvic organ prolapse procedures in New York state declined following a 2011 FDA warning, according to a new study.
      PubDate: Tue, 02 Feb 2016 19:00:01 -050
       
  • FDA Details When Human Factors Testing Is A Must
    • Abstract: FDA identified the device types that almost always need human factors, or usability, data included in premarket submissions in a draft guidance posted in conjunction with final guidelines with broader human factors testing recommendations.
      PubDate: Tue, 02 Feb 2016 17:30:01 -050
       
  • Device Firms Get Extra Time To Remove Drug Codes From Product Labels
    • Abstract: FDA is easing up on some Unique Device Identification compliance requirements to remove other codes from device labels to avoid supply chain or payment disruption.
      PubDate: Tue, 02 Feb 2016 16:55:02 -050
       
  • Health IT Groups Praise Goals Of Draft EHR Bill, But Question Mandates
    • Abstract: Electronic health records would have to be coordinated enough for users to view results of patient tests, see registry information, and access device data under a Senate HELP Committee draft bill calling for federal standards, but health IT groups say they would prefer a more voluntary approach.
      PubDate: Tue, 02 Feb 2016 16:50:02 -050
       
  • FDA, NIH Issue Joint Clinical Development Glossary
    • Abstract: The glossary includes terms commonly used in medical product development, with a focus on endpoints and biomarkers. NIH and FDA say they will employ the glossary to ensure consistent communications.
      PubDate: Tue, 02 Feb 2016 16:45:00 -050
       
  • Warning Letter Roundup & Recap – February 2, 2016
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Tue, 02 Feb 2016 13:45:01 -050
       
  • Stryker In Neverland: Firm Ups Focus On Averting Avoidable Events With
           Sage Acquisition
    • Abstract: Stryker will pay nearly $2.8 billion to buy Sage Products and its portfolio of products to prevent health care "never events," which hospitals are increasingly motivated to avoid.
      PubDate: Mon, 01 Feb 2016 18:50:01 -050
       
  • Warning Letter Close-Outs – January 2016
    • Abstract: Four FDA close-out letters were released in January.
      PubDate: Mon, 01 Feb 2016 18:45:07 -050
       
  • In Case You Missed It: Top 10 "Gray Sheet" Stories In January
    • Abstract: Our most popular content in January included exclusive analyses of 2015 FDA recalls, warning letters and approvals; business and legal news from Boston Scientific and Johnson & Johnson; a look at combination product reform efforts in the US; plans to improve postmarket surveillance in Europe; and more.
      PubDate: Mon, 01 Feb 2016 18:40:00 -050
       
  • Abbott Moves To No. 2 Spot In IVD Market With Alere Acquisition
    • Abstract: Abbott has agreed to pay $56 per share to acquire Waltham, Massachusetts-based Alere, building up its point-of-care diagnostics portfolio and moving to the number two position in the global IVD sector.
      PubDate: Mon, 01 Feb 2016 18:35:01 -050
       
  • Medtronic Expands Renal Disease Focus With Bellco Buy
    • Abstract: Medtronic has bought Bellco Health, adding the Italian company's hemodialysis products to its recently-formed Renal Care Solutions division.
      PubDate: Mon, 01 Feb 2016 18:20:00 -050
       
  • Device Week – February 1, 2016
    • Abstract: On this week's podcast, the "Gray Sheet" team discusses the latest in user fee negotiations, cybersecurity, sterile devices and interoperability, as well as a focus on Zika virus diagnostics, HeartWare International's abandoned acquisition, a Boston Scientific legal update and more.
      PubDate: Mon, 01 Feb 2016 00:03:23 -050
       
 
 
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