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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]
  • UK Votes To Leave The EU – What's Next For The Life Sciences'
    • Abstract: The UK government will have to engage in many years of bargaining over its future relationship with the EU, whether as part of the single market or under the umbrella of the World Trade Organization, as well with the countries with which the EU has trade agreements. What this means precisely for the device industry and oversight of devices in the UK remains to be seen.
      PubDate: Fri, 24 Jun 2016 12:25:25 -040
       
  • Deal To Fight Zika Virus Boosts NIH, CDC Efforts, But Offers No FDA Review
           Dollars
    • Abstract: A $1.1bn agreement between the House and Senate to fund the emergency Zika virus response gives millions of dollars to the Centers for Disease Control and Prevention, NIH, and HHS's biodefense unit, but leaves FDA with no extra funds to support reviews of Zika products. The deal would take dollars from Ebola funding and HHS Affordable Care Act efforts as an offset, and is opposed by the president, who says he will veto it.
      PubDate: Thu, 23 Jun 2016 18:05:01 -040
       
  • FDA Returns To MDUFA Table With High, Low Proposals
    • Abstract: The priorities-gap between FDA and industry in MDUFA IV negotiations is narrowing. In May, the agency returned with counter-proposals that reduce user-fee increases compared to its prior plans, though there is still at least a $160m difference from the most recent proposal that is public from industry.
      PubDate: Thu, 23 Jun 2016 17:00:00 -040
       
  • Most Borderline/Combo Products To Escape High-Risk Classification In EU
    • Abstract: The latest text to emerge for the EU’s future device regulation includes a risk-based approach to the classification of devices with substances that are absorbed by, or dispersed in, the human body, rather than the one-size-fits-all class III designation that was originally proposed.
      PubDate: Thu, 23 Jun 2016 16:00:00 -040
       
  • Republican Health-Care Plan Would Repeal ACA, Device Tax
    • Abstract: A Republican plan offered on June 22 by House Speaker Paul Ryan to overturn the Affordable Care Act would repeal the 2.3% device excise tax, and kill the Independent Payment Advisory Board and the CMS Innovation Center. It also promotes device regulatory reforms passed in the 2015 "Cures" legislation.
      PubDate: Wed, 22 Jun 2016 18:10:00 -040
       
  • Manufacturer Settles Foreign Bribery Allegations Linked To Distributor
           'Slush Fund'
    • Abstract: Analogic Corp. and its subsidiary BK Medical APS are paying almost $15m to settle allegations that BK conspired with distributors to commit fraud overseas.
      PubDate: Wed, 22 Jun 2016 17:15:00 -040
       
  • Real-World Evidence Is Versatile, Commissioner Califf Says: 'Use It For
           The Right Purposes'
    • Abstract: FDA Commissioner Robert Califf emphasizes that real-world evidence research is complementary to traditional randomized clinical trial research, and, when needed, can directly support it.
      PubDate: Wed, 22 Jun 2016 16:25:01 -040
       
  • House-Senate Conferees Fight Over Zika Funds As FDA Approves More Assays
    • Abstract: Emergency funding to battle the summer's mosquito-borne Zika threat is trapped in a military/VA spending bill. Conferees must find a compromise between the House's $622m bid and the Senate's $1.1b offer in the thin stretch of time when both chambers will be session before they adjourn on July 15.
      PubDate: Wed, 22 Jun 2016 14:00:01 -040
       
  • Plan To Sue A Slipshod Supplier To Recoup A Civil Litigation Judgment'
           When It Comes To Implantable Device Parts, You May Have To Think Again
    • Abstract: While negligent suppliers of failing components are typically sued by end-product manufacturers to recover their fair share of civil or government money damages, vendors that sell parts for most implantable devices are largely shielded from liability by a not-oft-talked-about federal act. The Biomaterials Assurance Act of 1998 "provides immunity for suppliers of components in medical devices based on the notion that it’s the manufacturer of the actual device that is responsible for ensuring the safety of the products before they’re put onto market," attorney Lauren Colton says. "And under that...
      PubDate: Wed, 22 Jun 2016 11:20:01 -040
       
  • Warning Letter Roundup & Recap – June 21, 2016
    • Abstract: QS problems noted at manufacturer of thermal coagulators and probes; maker of antibacterial envelopes failed to validate manufacturing processes. FDA released warning letters to two device companies this week.
      PubDate: Tue, 21 Jun 2016 18:20:01 -040
       
  • FDA Taps New Office of Device Evaluation Director From Industry
    • Abstract: Device industry veteran John Sheets has been appointed as the new director of FDA's premarket review office for devices. It’s the second time this year that CDRH has tapped an industry executive to lead one of its offices.
      PubDate: Tue, 21 Jun 2016 17:30:01 -040
       
  • Legal News In Brief
    • Abstract: A roundup of recent lawsuit developments in the medtech space, including cases involved Acclarent, Intuitive Surgical, NuVasive, Stryker, Abbott, and more.
      PubDate: Tue, 21 Jun 2016 15:15:02 -040
       
  • EU IVD Regulation: A New Scrutiny System For Diagnostics
    • Abstract: A European Union-centralized scrutiny system will be put into place for high-risk products under a new EU regulation for in vitro diagnostics that is heading toward adoption in the coming months.
      PubDate: Tue, 21 Jun 2016 15:10:02 -040
       
  • Tips For Recruiting, Reporting Trial Subpopulations In FDA Draft Guidance
    • Abstract: FDA instructs device manufacturers and agency staff on its expectations for designing and analyzing trials to reflect outcomes for patient subpopulations, and also provides recruitment tips in a June 20 draft guidance.
      PubDate: Mon, 20 Jun 2016 19:00:01 -040
       
  • FDA Declines To Add 510(k)s To Pediatric Data Guidance, But Does Address
           De Novos
    • Abstract: Industry has asked FDA to expand the scope of its guidance on extrapolating adult trial data to pediatric submissions to include 510(k)s. In a final guidance, FDA declined to do so, but it did expand the scope of the guidelines to include de novo applications.
      PubDate: Mon, 20 Jun 2016 18:30:01 -040
       
  • FDA Grants Class II Status For Power Morcellator Containment Systems
    • Abstract: The agency will require 510(k) clearance for the devices, which can be used to isolate tissue removed from the uterus during morcellation. However, labeling will need to state that the systems have not been proven to reduce the risk of cancer.
      PubDate: Mon, 20 Jun 2016 17:55:01 -040
       
  • Labs Get Extra Year To Adjust To Diagnostics Reimbursement Revamp
    • Abstract: CMS issued a long-awaited final rule that will establish a new market-based approach to setting lab-test payment rates. The Medicare agency was convinced to delay implementation by one year, to 2018, and to make other tweaks to its policy that industry stakeholders say will make the system more accurate.
      PubDate: Mon, 20 Jun 2016 17:20:02 -040
       
  • Device Week – June 20, 2016
    • Abstract: On this week's podcast, we discussed cybersecurity, colorectal cancer screening guidelines, tax and patent legal rulings, and a busy week from FDA with rules and guidance documents.
      PubDate: Mon, 20 Jun 2016 00:02:19 -040
       
  • Cybersecurity Experts Expand Focus on Devices, Defend FDA's Efforts
    • Abstract: The cybersecurity risk for medical devices and FDA's efforts to counteract it are getting growing attention from organizations not traditionally linked to the medtech space. While some worry the agency has been slow to enforce change others say it has done a good job of balancing the potential risks of such devices against the need for patients to have access to their treatments.
      PubDate: Fri, 17 Jun 2016 17:15:02 -040
       
  • Q&A: Digital Rights Group Worries Device Firms Could Abuse Digital
           Copyright Act
    • Abstract: The digital rights group the Electronic Frontier Foundation says it is concerned device makers will use the Digital Millennium Copyrights Act to prosecute security researchers who discover flaws in their product. The group submitted comments in response to FDA's postmarket cybersecurity draft guidance to press the matter.
      PubDate: Fri, 17 Jun 2016 14:30:01 -040
       
  • Task Force Grants Broad Support For Colorectal Cancer Screening Tools
    • Abstract: The US Preventive Services Task Force said colorectal cancer screening is effective for those aged 50 to 75. It recognizes the potential for a range of methods, from standard colonoscopy to CT colonography, to blood and fecal DNA testing, to be used to increase screening rates.
      PubDate: Thu, 16 Jun 2016 18:00:02 -040
       
  • FDA, AAMI Explore How To Consider Benefits, Risks In Postmarket
    • Abstract: FDA has already put a lot of work into mapping out pathways for weighing benefit versus risk in premarket review decisions. Now the agency, with the help of the Association for the Advancement of Medical Instrumentation and industry, is trying to provide the same support for compliance and enforcement decisions.
      PubDate: Thu, 16 Jun 2016 17:45:00 -040
       
  • FDA Biocompatibility Guidance Adds Nanotech, Absorbability Test Tips
    • Abstract: A June 15 FDA final guidance on biological evaluation of devices adds new sections on biocompatibility testing compared to the 2013 draft version, including a risk-based approach to biocompatibility testing, as well as test article preparation recommendations for devices with submicron/nanotech components, in situ polymerizing or absorbable materials, and tips for chemical testing.
      PubDate: Thu, 16 Jun 2016 17:30:01 -040
       
  • FDA Funding Debate Reframed By GAO Reports On Strategic Planning
    • Abstract: Republican senators argue that new Government Accountability Office reports critical of FDA's efforts to track its strategic plan and regulatory science progress show that that agency needs significant reform.
      PubDate: Thu, 16 Jun 2016 12:00:01 -040
       
  • Terumo Makes Big Bet On Aneurysm Embolization With Sequent Acquisition
    • Abstract: The $280m-plus acquisition fits with Terumo's strategy to grow its neurovascular device business, which it entered 10 years ago. Terumo will also pay Sequent’s owners another $100m based on the achievement of specific development or commercial milestones.
      PubDate: Wed, 15 Jun 2016 16:00:00 -040
       
 
 
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