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    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 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 23 August 2018 to include: FDA is adding  Chikungunya virus disease, lassa fev...
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    Regulatory Recon: A Changing of the Guard (2 July 2015)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Today is my last day working at RAPS and writing Regulatory Reconnaissance ( more on that here ). Thank you all for your readership over the years. It's been incredible to see this morning news roundup grow from something read by 50 people per day to something read by 2,000 people every morning. Fear not: Regulatory Recon isn't going away. News Editor Michael Mezher will be takin...
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    FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program

    The US Food and Drug Administration (FDA) has released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development (PFDD) program—an integral part of the most recent authorization of the Prescription Drug User Fee Act (PDUFA). The PFDD was created in an attempt to bring patients into the regulatory process in a more systematic way. Instead of asking for patient feedback on a drug-by-drug basis, the PFDD asks ...
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    Regulatory Recon: WHO Weighs in on Biosimilar Naming (1 July 2015)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. A quick note from your editor: After five wonderful years working at RAPS, my last day will be on 2 July 2015. More on that here . You have my sincerest thanks for your readership over the years. Regulatory Recon will live on under a new editor. In Focus: US Congress Moves to Block Human Embryo Editing, FDA Approval of INDs ( SciAm ) Must FDA-Regulated Companies "Allow" FDA...
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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...
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    FDA Exempts 120 Medical Device Types from Most Regulation

    The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices. Background Under existing regulations, FDA regulates devices according to three general categories: Class III – High-risk devices; require the submission of a Premarket Application (PMA). Class II – Moderate-risk devices; require the submission of a Premarket N...
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    Regulatory Recon: FDA Sued by Groups Seeking Access to Clinical Trials Data (30 June 2015)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. A quick note from your editor: After five wonderful years working at RAPS, my last day will be on 2 July 2015. More on that here . You have my sincerest thanks for your readership over the years. Regulatory Recon will live on under a new editor. In Focus: US FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data ( Pharmalot ) ( Law 360 -$) ( Reuters ) Is the...
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    FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

    A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir). Background Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies subm...
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    FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

    It is an iconic image replicated during almost every single infectious disease outbreak in the last century: men and women clad head to toe in surgical gowns and surgical masks, tending to the sick or working to disinfect contaminated areas. But iconic or not, the US Food and Drug Administration (FDA) has a more pressing concern: Are the gowns effective at protecting their users from the spread of infection? Background The question is the focus of a new draft guidance d...
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    From the Editor: A Fond Farewell

    All things—even the best things—must eventually come to an end. After five wonderful years working at RAPS, including the last four writing for Regulatory Focus , this week will be my last writing for the publication. My last day as Managing Editor will be on 2 July 2015. Don't worry— Regulatory Focus isn't going anywhere. Our existing staff, including Michael Mezher, Zac Brousseau and Gloria Hall, will make sure you still receive the high-quality news and information...
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    Regulatory Recon: Jail Time for Former Medical Device CEO Over Regulatory Infractions (29 June 2015)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Former OtisMed CEO Sentenced To Two Years For Selling FDA-Rejected Knee Devices ( Gray Sheet -$) ( FDA ) FDA gives nod to newest pelvic mesh product, despite ongoing safety issues ( Fierce ) Will Combination Products Join The User Fee Family? ( Pink Sheet -$) Not All Devices are Created Equal: UDI Direct Marking ( FDA Law Blog ) Breakthrough Designation Is A Two...
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    FDA Dials in on MRI Safety of Passive Implantable Medical Devices

    For the second time in a year, the US Food and Drug Administration (FDA) has released new guidance intended to ensure the safety of implanted medical devices from magnetic resonance imaging (MRI) devices. Background In medicine, the context of a product's use is very often the difference between a product that cures and one that kills. For example, a medicine given in the wrong dose or to the wrong patient might leave someone injured or dead. But for medical devices, t...