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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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    NICE to Charge up to £282,000 for Each New Drug Assessment

    The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year. News of the new fees stirred controversy in London’s Sunday Times , and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance: “Charging pharmaceutica...
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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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    Pharma Companies Call on FDA to Make Clinical Outcome Assessment Pilot More Useful

    More than a dozen drug developers, including Pfizer, Genentech, Sanofi and GlaxoSmithKline, and industry groups are calling on the US Food and Drug Administration (FDA) to ensure that a clinical outcome assessment (COA) pilot program includes more useful information for researchers. Background The pilot project, first proposed by FDA in January , is intended to help industry with a starting point for considering how certain COAs might be used in clinical trials and ear...
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    FDA: 'No Significant Impact' to Environment From Genetically Engineered Mosquito Trial

    The US Food and Drug Administration (FDA) on Friday said that a proposed trial to release genetically engineered mosquitoes in Key Haven, FL poses no significant threat to the environment. The mosquitoes, referred to as OX513A, are a modified strain of the Aedes aegypti mosquito developed by the UK-based Oxitec Ltd. The mosquitoes are modified so that most of their offspring die before reaching maturity, and have been altered to include a red fluorescent marker to mak...
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    Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs

    A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document. The draft guidance from December calls on sponsors to create a safety assessment committee (SAC) to review safety information in a clinical development program and make recommendations to the sponsor ...
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    US, EU & WHO Launch Efforts to Accelerate Zika R&D

    One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease. Obama Calls for $1.8 Billion in Funding On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad. N...
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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...
  • TGA Offers Guidance on How Device Makers Can Reduce Assessment Fees by 70%

    Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled new guidance on the eligibility requirements for medical device and in vitro diagnostic (IVD) companies looking to reduce assessment fees by as much as 70%. The reduction in fees could save industry a significant amount of money as, according to the new fees published in July by TGA, conformity and audit assessment fees can range from about $4000 to more than $50,000, depending on the type of assessm...
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    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
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    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
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    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...