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  • Regulatory NewsRegulatory News

    FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity. Known as  adaptive design , the method can minimize clinical trial sponsors’ resou...
  • Regulatory NewsRegulatory News

    EMA in 2014: A Landmark Year for Approvals, With Eyes on the Future

    In the European Medicines Agency's (EMA) Annual Report 2014 , top regulatory officials describe the agency's role as both a "gatekeeper" and "enabler." This dual role means that the agency must not only work to ensure the safety of patients in the EU, but also to facilitate the development of new and innovative therapies. By the Numbers 2014 was a landmark year for EMA in many ways. The agency recommended record numbers of products to treat rare diseases , launched it...
  • 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...
  • IOM Report Envisions 'Transformed Clinical Trials Enterprise' in US

    A report released by the US Institute of Medicine (IOM) looks at the future of the US' clinical trials enterprise, and finds a growing gap between the demand and capacity for high quality evidence to support medical treatment decisions. The report, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020 , is a summary of a November 2011 workshop conducted by the IOM's Forum on Drug Discovery, Development and Translation...