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    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    FDA Proposes Radiological Health Deregulatory Action

    The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems. The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic ther...
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    FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

    After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices. FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act...
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    Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office. The hearing centered on the mammoth new law that includes major tweaks to how FDA regulates drugs, devices and biologics, and provides ...
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    FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

    The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices. While x-ray imaging can increase the risk of cancer for both adult and pediatric patients, FDA says that radiation is a greater concern for pediatric patients as they are more sensitive to radiation and have a longer expected lifetime during which cancer could develop. FDA also says that x-ray imaging devices...
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    FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

    The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT). FDA said in a letter sent to the company in late July that it has not yet submitted its pediatric assessment, which was identified in the BLA’s approval letter fro...
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    FDA Updates Guidance on Collecting Race, Ethnicity Data in Clinical Trials

    The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices. According to the agency, the guidance has been updated to reflect a standardized approach to collecting race and ethnicity data in accordance with requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Inn...
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    New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays

    The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product. The guidance, Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices , replaces the agency's 1999 guidance of the same name. In some cases, FDA says that "nonclinical information may be sufficient to support the substan...
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    Pediatric Study Plans: FDA Unveils Revised Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted. This revision, which FDA says was based largely on public comments, includes additional clarifications on the 2013 draft guidance, such as new information on what constitutes a materially incomplete initial pediatric study plan (iPSP), th...
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    House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

    The House Energy and Commerce Committee is asking the National Institutes of Health (NIH) for more information on how the temporary closure of its drug manufacturing facility has impacted patients in NIH clinical trials. Background The US Food and Drug Administration (FDA) earlier this summer uncovered a series of deficiencies at NIH's Pharmaceutical Development Section (PDS), which acts as a specialty compounding pharmacy managing investigational drugs for clinical tri...
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    FDA Finalizes Six-Month Drug Shortage Notice Regulation

    A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages. Background In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the response to drug shortages through stronger notification re...
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    Patient-Focused Drug Development Tracker

    Since the passage of the  Food and Drug Administration Safety and Innovation Act (FDASIA)  in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process. Those meetings have raised novel questions for regulators, who for the first time are asking patients and patient groups to ex...