• Regulatory NewsRegulatory News

    505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times

    With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA

    Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...
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    A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

    With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes. Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Spe...
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    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
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    New Report Investigates Use of Analytics to Measure Medical Device Quality

    The Case for Quality, a public-private partnership between the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC), has released a new report on the feasibility and effectiveness of using analytics to measure medical device quality in healthcare decision-making. In order to measure these factors, a Case for Quality working group ran a pilot focusing on knee and defibrillator implants at seven hospitals to determine whether data, both...
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    Senate Committee Advances Five More Bills as Part of Medical Innovation Package

    The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill. Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats. “With its 21st C...
  • Feature ArticlesFeature Articles

    Advancing Regulatory Science: Research Success in a Public-Private Partnership

    This article discusses how a public-private partnership brought stakeholders together to advance regulatory science research in patient preference assessment. In May 2015, the Medical Device Innovation Consortium (MDIC) published a first-of-its-kind report, "A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology." 1 This "Framework" is not only a break-through publication in the...
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    FDA Calls Out Pathway Genomics for Marketing Unapproved Cancer Test

    Pathway Genomics is currently marketing an unapproved screening tool, which the US Food and Drug Administration (FDA) believes to be a medical device, for the early detection of up to 10 different cancer types, the agency said in a letter to the company this week. FDA says that the non-invasive blood test, known as CancerIntercept Detect, "appears to meet the definition of a device" as the company ships blood collection tubes, a medical device, for use with the tool. "W...
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    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
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    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
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    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...