• Regulatory NewsRegulatory News

    EMA to Continue Parallel Scientific, HTA Advice Following Successful Pilot

    The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs. Due to the success of the pilot, which concluded on Wednesday, EMA says it will continue to offer parallel scientific advice as part of its routine activities. "Our parallel scientific advice fosters...
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    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
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    FDA Plans Pilot Project on Clinical Outcome Assessments

    As part of the US Food and Drug Administration’s (FDA) work on patient-focused drug development, the agency is launching a pilot project where it will collate and summarize clinical outcomes on a number of different diseases in one online resource. The clinical outcome assessment (COA) pilot project, announced Wednesday, is intended to be a starting point for companies considering how certain COAs might be used in clinical trials and early drug development. COAs for th...
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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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    MDSAP to Continue Past Pilot Phase in 2016

    Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday. MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to tr...
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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...
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    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...
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    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...
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    Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE

    US manufacturers seeking clearance for a new device usually submit a Traditional 510(k) application, also known as a Premarket Notification (PMN) or Premarket Approval (PMA) application, to the Food and Drug Administration (FDA). The submission type depends on the device’s regulatory classification under 21 CFR 862–892. Most Class I devices are exempt from the 510(k) requirement; most Class II and a few Class III devices must have a cleared 510(k); and most Class II...
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    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...