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    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
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    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
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    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
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    EC Report Calls for New Network of Reference Labs for Human Pathogens

    The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday. Currently, many national reference labs for human pathogens have a hard time responding in a coordinated manner to new and emerging infectious threats. The aim of an EU-wide network would be to better respond to cross-border threats, a...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

    The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...
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    New Fundamentals of US Regulatory Affairs Book Now Available

    RAPS has just published the updated, ninth edition of Fundamentals of US Regulatory Affairs , the book that has become one of the most essential references for regulatory professionals working with healthcare products for the US market. The new edition is now available  in a print, hardcover edition or as an e-book. RAPS currently is offering free shipping for the book and for all orders from the RAPS Store through 31 August. Fundamentals of US Regulatory Affa...
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    FDA Will Soon Need to Publish More Information About the Outside Standards it Uses

    The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with. Background If you're in the regulated healthcare products space—and in particular are involved with medical devices —you probably already know a thing or two about standards. There are of course standards FDA creates...
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    FDA Issues Guidance on 'Substantial Equivalence' Process Used to Bring Devices to Market

    The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how regulators will evaluate applications in order to determine "substantial equivalence." Background The 510(k), or premarket notification, process differs from the premarket approval process in that regulators are partially assessing the safety and efficacy of the device based on its subst...
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    FDA Releases 33 New Medical Device Standards

    US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards. In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards. Those standards come to be recognized by FDA through a process known as "i...
  • EMA to Allow Biosimilar Applications to Reference Data from Products Approved Outside EU

    The European Medicines Agency (EMA) has announced its intent to accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA), allowing companies an alternate and potentially easier route to obtain approval for new biosimilar products in the EU. Biosimilars, also known as follow-on biologics or similar biological medicines, are highly similar versions of already-approved biologics medicines. Unlike generic pharmaceutical products, which...
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    Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators

    An emerging class of biological products intended to act as the generic equivalents of earlier, branded products is being threatened globally by an obvious, yet complex set of issues, say two experts consulted by Regulatory Focus . The products-known as biosimilars, follow-on biologics or subsequent entry biologics-are intended to act as interchangeable substitutes for other biological products whose patents have expired and are thus eligible for market competition. Whi...