• Regulatory NewsRegulatory News

    CDRH Plots Path to New 'Progressive' Approvals for Some Devices

    With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted. Jeff Shuren, director of CDRH, speaking by teleconference at the MedCon conference in ...
  • Feature ArticlesFeature Articles

    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
  • Regulatory NewsRegulatory News

    FDA Offers New Guidance on Interpretation of BPCIA

    The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Put simply: FDA will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020.  The provision in the BPCIA states that: "An approved application for a biologi...
  • Regulatory NewsRegulatory News

    EMA Spells Out New Expectations for Adaptive Pathways Applications

    The European Medicines Agency (EMA) has issued a new guidance to help companies applying to its adaptive pathways pilot. Background EMA launched its adaptive pathways pilot in 2014 to speed access to new medicines in areas of "high medical need" by leveraging existing approval pathways to support "early and progressive patient access" to new medicines. Under the pilot, drugs would either be authorized conditionally or in a staggered fashion by narrow indication befor...
  • Regulatory NewsRegulatory News

    Six Drugs Selected to Advance in EMA's Adaptive Pathways Pilot Program

    The European Medicines Agency (EMA) recently announced that it has selected six drugs to move forward in its adaptive pathways (formerly adaptive licensing) pilot program. Background In March 2014 EMA announced it would be launching an adaptive pathways pilot program that would seek to accelerate patient access to drugs intended to treat serious unmet medical needs. The adaptive pathways program would allow drugs to receive approval for use with a narrow indication o...
  • Regulatory NewsRegulatory News

    EU Adaptive Licensing Program Moves Forward, With More Clarity for Sponsors

    The European Medicines Agency (EMA) wants to make it easier for companies to use its adaptive licensing pilot program, a new effort to grant accelerated access to medicines intended for limited populations of patients with serious unmet medical needs. Background The adaptive licensing pilot program was first announced in March 2014, and is an attempt to move beyond clear-cut yes-or-no approval dichotomies, and to instead allow some drugs to be approved for limited pop...
  • Regulatory NewsRegulatory News

    EMA Adaptive Licensing Project Moves Forward, Two Candidates in Tow

    In March 2014, the European Medicines Agency (EMA) announced that it would soon launch a new pilot program intended to grant "adaptive licenses" to medicines, permitting patients with unmet needs to access the medicines far earlier than they would otherwise. Now EMA has announced that the program is up and running, and that regulators have already accepted the first two medicines into the program, with another four waiting in the wings. Background EMA's adaptive...
  • EMA Unveils New Adaptive Licensing Initiative, Meant to Provide Earlier Niche Approvals

    The European Medicines Agency (EMA) has announced that it will be launching what it's billing as an "adaptive licensing pilot project," an initiative intended to grant earlier access to medicines meant to treat unmet needs. Unlike the US' accelerated approval pathway, which grants a tentative but wide-ranging approval to a product based on interim data, EMA's adaptive licensing framework calls for the authorization of medicines for restricted (i.e. niche) patient populat...