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    Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

    This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps. The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality an...
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    Integrating FDA Meetings into a Medical Device Regulatory Strategy

    This article focuses on the strategic use and suitability of a Q-Submission program. Introduction An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the...
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    FDA Seeks Participants for Emerging Pharma Manufacturing Tech Program

    The US Food and Drug Administration (FDA) is looking for companies to participate in a program that will review the latest in cutting-edge pharmaceutical manufacturing technology. For companies submitting an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufac...
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    FDA Seeks Info on New Tech Helping Conduct Clinical Research

    The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research. The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it's requesting more information on the challenges associated with collecting data on trial participants' own devices, which FDA says may be used to access and respond to ...
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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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    Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

    Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...
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    The Key to EU Market Access for Pharmaceutical Companies: Early Engagement

    The path to regulatory approval can be long and arduous. It can also be especially difficult for smaller companies to navigate. But a new report finds that early input from health authorities can help make the process more straightforward. The report is based on information gathered through interviews with small- and medium-sized biotechnology companies, the European Medicines Agency (EMA) and HTA bodies. The report finds early engagement with regulatory authorities an...
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    Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

    A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports. The researchers, led by Beate Wieseler, head of the department of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG), wanted to determine if the reporting requirements for early benefit assessment in Germany yielded more comp...
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    German Price Watchdog Says ‘No’ to 3 Cancer Drugs

    The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month. IQWiG is one of several bodies in Germany charged with conducting health technology assessments (HTAs) for newly approved drugs in Germany. The goal of these assessments is to weigh the benefit of new therapies against the costs to the country’s healthcare system. According to IQWiG’s assessment, the drugs idelalisib , sipuleucel...
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    FDA Cancels Study of How it Can Use Drones to Conduct Inspections

    The US Food and Drug Administration (FDA) is no longer considering the use of aerial drones to help assist its on-site inspections of facilities, less than 24 hours after initially saying feasibility studies were in the works. As first reported by Regulatory Focus , on 16 December 2014 FDA sent an email to staff indicating that it planned to test the use of drone technology for its potential applications "in the areas of manufacturing site inspections, farm inspection...
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    FDA Studying How it Can Use Drones to Conduct Inspections (Updated)

    The US Food and Drug Administration (FDA) is considering the use of aerial drones to help assist its on-site inspections of facilities, the agency confirmed to Regulatory Focus this week. UPDATE: FDA has cancelled its preliminary feasibility testing. While there is currently "no formal drone program in development," the agency is currently "conducting preliminary feasibility testing on possible applications for drone technology in fulfillment of the agency's mis...
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    Congress Skeptical About FDA, ONC Effort to Coordinate on Health IT Regulation

    In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law. Background In 2012, the  Food and Drug...