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    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...
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    New Senate Bill Would Change the Way FDA Regulates Devices

    A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices. The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also: Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internati...
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    New Senate Bill Looks to Help FDA Attract Talent

    The Senate’s response to the House-passed 21st Century Cures bill is slowly shifting into a series of bills, the latest of which would seek to help the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) attract top new employees. Chairman of the Senate HELP Committee Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) introduced the bill, known as the FDA and NIH Workforce Authorities Modernization Act , which enables FDA t...
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    Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research

    The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year. The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the Nationa...
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    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
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    End in Sight for Discussions Over New EU Medical Device Regulations

    New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday. The legislation would introduce stricter premarket rules for a range of medical devices, increase the powers and responsibilities of notified bodies and require new clinical evidence in some cases. On 5 October 2015, the Ministers of the EU countries agreed on a gene...
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    Bipartisan Clinical Trials Compensation Bill Heads to Obama for Signature

    Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases. If signed by President Barack Obama, the legislation -- the Ensuring Access to Clinical Trials Act of 2015, which passed the Senate in July -- would enable those with rare diseases to receive compensation of up to $2,000 for participating in clinical trials without having the compensati...
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    Bipartisan Group of Senators Introduces Bill to Speed Development of Rare Disease Drugs

    A new bipartisan bill aims to help accelerate the development of targeted drugs to treat rare diseases, including Duchenne muscular dystrophy, cystic fibrosis, some cancers and other genetic diseases. Although it's unclear how exactly the bill will aid in the development of targeted rare disease treatments, one of the cosponsors, Sen. Elizabeth Warren (D-MA), said the bill would clarify the US Food and Drug Administration's (FDA) current authority to consider resear...
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    FDA Legislation Tracker

    Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...
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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...
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    Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill

    An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...
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    Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women

    New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA). The bill, the Research for All Act , was previously introduced in 2014 by Reps. Jim Cooper (D-TN) and Cynthia Loomis (R-WO), and was reintroduced in the House on 29 April 2015. Background At its core, the bill aims to address something long known by regulators and medical research offi...