• Regulatory NewsRegulatory News

    CDRH Develops 'Regulatory Toolkit' to Promote Device Innovation

    Officials from the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) say their efforts to develop a "regulatory toolkit" for sponsors has helped promote medical device innovation in the US, according to a recent viewpoint in JAMA Ophthalmology . While fostering innovation has been one of CDRH's strategic priorities since 2010, reports that growth in device clinical trials in the US had fallen behind other countries, including Braz...
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    EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

    The European Medicines Agency’s (EMA) five-year-old policy of allowing some academic researchers and journalists to access what’s considered commercially confidential information in the US has resulted in a lengthy process that can take considerable back and forth correspondence with the agency, according to a new study. Since 2010, EMA has allowed clinical study reports to be subject to its “reactive” freedom of information policy, which makes it the only regulator in t...
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    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
  • Feature ArticlesFeature Articles

    FDA Expanded Access Pathways

    This article discusses the various US regulatory pathways for access to investigational drugs and medical devices outside a clinical trial. Patients requiring diagnosis, monitoring or treatment for a serious disease or condition rely on medical products (drugs including biologics and medical devices) approved by the US Food and Drug Administration (FDA). When appropriate therapeutic products are not available on the market, patients can enroll in clinical trials to acc...
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    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
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    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
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    'Right to Try' Legislation Tracker

    Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use ," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for...
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    RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

    No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...
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    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...
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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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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
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    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...