• Regulatory NewsRegulatory News

    Clinical Trials: FDA Releases Two Draft Guidances

    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial. The draft also advises sponsors on the types of information FDA needs to evaluate the results from trials with adaptive designs,...
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    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
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    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...
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    European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Schedules Workshop to Discuss Adaptive Pathway Program The European Medicines Agency (EMA) has scheduled a meeting to hear what drug developers and other groups have to say about its adaptive pathways program. EMA is presenting the workshop as an opportunity to discuss the lessons of the two-year pilot program and figure out the future of the staged approach to drug app...
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    EMA to Continue Adaptive Pathways Program as Pilot Ends

    The European Medicines Agency (EMA) on Wednesday published a final report on its experience from its adaptive pathways pilot project, noting that a few aspects of the program need to be further improved and refined moving forward.  Though the vast majority of applications for the pilot were rejected, EMA said that moving forward, the agency needs to further integrate the patient voice into the program and refine the definition of methodologically sound strategies for col...
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    FDA Finalizes Guidance on Adaptive Designs for Device Studies

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity. FDA says it received 151 comments from seven entities , including the Advanced Medical Technology Association (AdvaMed) and AstraZeneca, on the draft guidance and “incorporated most of them in this final guidance.” Guidance Adaptive trial designs , first...
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    EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program. Background First announced in March 2014, EMA’s pilot program seeks to accelerate patient access to drugs for patients with pressing medical needs and after approval for a narrow...
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    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...
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    EMA Executive Director: Agency Ready for Challenges Ahead

    The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term. In his first press briefing since being reinstated as Executive Director of EMA in November, Rasi says he sees three major factors that will set the tone during his term. First, Rasi says "our understanding of the human body and the underlying science [of medicine] has vastly grown" in recent years. To meet this chal...
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    European Regulatory Roundup: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA to Stop Accepting Submissions on Physical Media in February The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is to stop accepting submissions for medicines licenses on physical media on 1 February 2016. MHRA has decided to drop support for physical media after talking to trade groups about the use of the format. Having completed the...
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    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...
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    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...