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    AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

    In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.   The five-pronged action plan— revealed in April—consists of establishing a medical device safety net, exploring regulatory options for postmarket mitigations, spurring innovation towards safer devices and further strengthen...
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    FDA Extends Malfunction Summary Reporting Program to Combo Products

    In a Thursday notice finalizing a new industry program for reporting device malfunctions, the US Food and Drug Administration (FDA) announced it has extended the eligibility of manufacturers that can chose to participate to include those with combination products.   The Voluntary Malfunction Summary Reporting Program was first proposed last December as an alternative to reporting certain device malfunctions via medical device reports (MDRs) with the goal of reducin...
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    Experts Call on Congress to Hold Drug Companies Liable in Failure-to-Warn Cases

    The authors of a new JAMA viewpoint argued generic and brand companies are currently protected in most jurisdictions in cases over failures to warn of adverse drug effects.   “It is a troublesome feature of current law that a patient harmed by a generic drug may have no legal recourse to pursue a failure-to-warn claim,” write JAMA deputy editor Gregory Curfman and Marcia M. Boumil, a professor at Tufts University School of Medicine. “Congress should fully consider ...
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    CRO’s Improper Specimen Storage Draws FDA Warning

    An international contract research organization (CRO) drew a warning letter from the US Food and Drug Administration (FDA) based on an inspection that revealed violations of good laboratory practices (GLP), including the storage of specimens in “a tissue and supply closet.”   The FDA’s inspection of North American Science Associates (NAMSA), which provides regulatory consulting, laboratory testing and clinical research services to the medical device industry, was condu...
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    Recon: Biogen’s Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US New York sues OxyContin maker Purdue Pharma over opioids ( Reuters ) Tech Giants Pledge to Ease Patient, Provider Access to Health Data ( WSJ ) ( The Hill ) Flagship Pioneering’s Sigilon gets a new CEO ( STAT- $) ( Endpoints ) ( Fierce ) Acorda Therapeutics CTO Leaves To Helm Unnamed Biotech Company ( BioSpace ) ( Fierce ) Carl Icahn Backs Off C...
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    Gottlieb: FDA Approvals for Pediatric Devices Continue to Lag

    T he past decade has seen “far too few devices” on the US market designed specifically for diagnosing and treating pediatric populations despite recent legislative actions, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said during a public workshop Monday.   The pediatric device sector is fraught with challenges, noted participants at the first day of the two-day workshop, which forms part of a renewed push for pediatric medical device development....
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    FDA to Study Drug Risk Information in DTC Print Ads

    The US Food and Drug Administration (FDA) said Monday it plans to conduct an experimental study on consumer impact from the amount and placement of risk information in prescription drug ads.   Sponsors tend to include risk information in both the “Important Safety Information” (ISI) section in direct-to-consumer (DTC) print ads and in a consumer brief summary, according to FDA.    “Including risks in both the ISI and the brief summary may have advantages,” FDA said...
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    Recon: Regeneron’s Eylea Stumbles as FDA Issues CRL; Amicus Sets $315,000 Price for Fabry Disease Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Drug pricing watchdog group targets California Dem in $500K ad buy ( The Hill ) ( STAT ) Amicus sets $315,000 price for new Fabry disease treatment ( Reuters ) ( STAT ) ( Endpoints ) St. Jude and Mustang Bio enter into exclusive worldwide license agreement ( Memphis Business Journal -$) ( Endpoints ) ( Fierce ) MD Anderson, Accelerator bake up Mag...
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    FDA Approves First Contraceptive Mobile App

    A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use.   The Natural Cycles app features an algorithm that supports fertility awareness by gauging days of likely fertility based on menstrual cycles and daily body temperature data submitted by users.   To approve the app via the de novo pathway, the agency evaluated results from clinical studies that showed ...
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    Recon: China Targets 48 Drugs for Priority Approval; Astellas Expands Eye Disorder Pipeline

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves first targeted RNA-based therapy ( FDA ) ( Endpoints ) ( Stat ) ( WSJ ) Nebraska Plans First Execution in 21 Years. Not So Fast, Drug Company Says. ( NYT ) Former Drug Company Official Pleads Guilty In Fraud and Kickback Scheme That Cost Medicare Millions ( Hartford Courant ) ( NJ.com ) Walden Holds Roundtable on Opioid Crisis with FDA Commissi...
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    Combo Products: FDA Delays Compliance Date for UDI Submissions

    Manufacturers of combination products reviewed at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) received a year-long extension on Thursday to comply with certain unique device identification (UDI) requirements.   The extension on the compliance date for the device components of co-packaged and cross-labeled combination products relates to the requirements on data submissions to FDA’s Global UDI Database (GUDID) under the 201...
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    TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

    Australia’s Therapeutic Goods Administration (TGA) is calling on industry to help tackle existing regulatory challenges in the medical device areas of software and cybersecurity.   “To continue providing a clear regulatory environment for medical devices in Australia, it is essential that we engage with the medical devices ecosystem during the development of new regulatory recommendations and guidelines,” TGA said in a notice posted Tuesday.   The regulatory author...