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    Plans for US Evaluation System for Medical Devices Take Root

    The US Food and Drug Administration (FDA) is going to make a big push over the next two years to use more real-world evidence to track the safety of medical devices. The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to leverage real-world evidence to more quickly identify safety signals, particularly through ...
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    FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

    The US Food and Drug Administration (FDA) does not have reliable, readily accessible data on safety issues and postmarket studies for drugs approved through expedited review pathways, the Government Accountability Office said in a report released Thursday. The report dug into FDA’s Center for Drug Evaluation and Research (CDER) data, which received about 1,000 requests for fast track designation and breakthrough therapy designation (the other two expedited programs for r...
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    Tufts Outlines Regulatory Initiatives to Spur Innovation in 2016

    Further harmonization among major regulatory agencies globally will look to focus on pediatric drug studies in 2016, according to a new report from the Tufts Center for the Study of Drug Development. The report released this week outlines not only what the drug development industry should expect for 2016, but also how regulators will play a major role in keeping drugs safe and in some cases extending marketing exclusivity periods for certain classes of drugs deemed crit...
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    EMA Issues Draft Guidance on Post-Authorization Efficacy Studies

    The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstanc...
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    Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance

    Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews. Challenges in Orphan Drug Development In August, FDA released a draft guidance intended to address the most common issues faced by drugmakers developing treatments for rare diseases . The guidance notes that FDA's "regulations provide flexibility in applying regulatory standards" a...
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    GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive

    Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report. Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a...
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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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    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...
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    EMA Hopes to Boost Drug Safety in Scientific Advice Pilot

    In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS). Background Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines. The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate rob...
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    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
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    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
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    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...