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  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
  • Regulatory NewsRegulatory News

    FDA Proposal Explains Uses for New Innovation Funds

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) over the next eight years will have access to more than $500 million in new funds for a variety of new drug, device and clinical trial work. According to a proposal of how these new funds would be used, subject to the congressional appropriations process, FDA said on Friday the bulk would be dedicated to sections of the law on “Advancing New Drug Therapies” and “Patient Access to Ther...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance

    A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI). Background FDA's Critical Path Initiative was created in March 2004 as an attempt to identify and dismantle unnecessary roadblocks to new product innovation and regulatory approval. These roadblocks, which would exist on a product's "critic...
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    UK Regulator Touts its Involvement in Domestic Manufacturing Site

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is once again touting its efforts to bolster manufacturing innovation, releasing a case study explaining its role in the redevelopment of a local manufacturing site. Background In 2013, MHRA launched its Innovation Office, with the goal to provide advice and assistance to companies working on novel treatments or manufacturing processes. The Innovation Office encourages companies to contact them e...
  • Regulatory NewsRegulatory News

    Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients

    Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective. Background FDA's regulation of sunscreen ingredients popped up as a major issue starting in late 2013, when sunscreen manufacturers banded together to form a coalition ...