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    Formal Dispute Resolution: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Friday finalized its guidance on the system for formally disputing scientific or medical issues between a sponsor and the agency. While the guidance remains largely similar to the agency's revised draft version issued in September 2015, FDA says it has provided clarifications on several issues and updated the guidance to reflect changes to its dispute resolution goals for generic drugs under the reauthorized Generic Drug Us...
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    FDA To Disclose Unredacted Advisory Committee Members' CVs

    In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members. A consent form saying the member’s CV does not include any confidential information will need to be submitted, FDA said. Background FDA maintains about 50 advisory committees comprised of outside experts who weigh in on scientific and medical issues, and which typically convene ...
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    FDA Helps Fund 21 Early Phase Trials for Rare Disease Treatments

    The US Food and Drug Administration (FDA) on Monday announced it is awarding $23 million in research grants for 21 new clinical trials over the next four years to boost the development of rare disease treatments. The grants, awarded to researchers from academia and industry at domestic and international clinical sites, are part of FDA’s Orphan Products Clinical Trials Grants Program, created in 1983, which has provided more than $370 million (including $19 million ...
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    FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

    A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010. "We are concerned by these findings," write Dr. Vinay Prasad and his colleague Dr. Jeffrey Bien at the Oregon Health & Science University, "The transition from regulator to advising companies seems logical but it raises questi...
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    FDA Issues New Guidance on Conflict of Interest for Advisory Committee Members

    The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest. FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. These committees are typically convened when FDA wants input on a n...
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    FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest

    The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...
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    FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...
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    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
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    FDA Updates Guidance on Resolving Scientific, Medical Disputes

    The US Food and Drug Administration (FDA) has further clarified and updated its guidance on the system for resolving complicated medical and scientific disagreements between drug sponsors and the agency. The draft guidance is meant for cases when a sponsor may disagree with FDA and a dispute arises. The disputes often involve complex scientific and/or medical matters, so FDA deems it critical to have procedures in place to help ensure an open, prompt discussion. The rev...
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    Public Health Advocates Worry EMA and Industry are Too Cozy

    A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry. Background Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees. Generally, industry has been supportive of regulators charging fees for these services (although somet...
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    EMA to Close 'Revolving Door' Between Reviewers and Industry

    Members of scientific and expert committees at the European Medicines Agency (EMA) will no longer be able to take part in the evaluation of medicines if they intend to work for a pharmaceutical company. Background In 2012, EMA came under fire from the European Court of Auditors (ECA), after an audit uncovered a number of shortfalls in the agency's conflict of interest (COI) policies. At the time, ECA made recommendations to EMA intended to improve the agency's CO...
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    Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds

    Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues. Background The paper comes as several research papers in recent years have made the opposite case—that advisory committee members with stated conflicts of interest do affect how a committee makes a decision. For example, a September 2014 paper in the journ...