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    FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

    Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday. The life-saving medication is indicated for stopping or reversing the effects of an opioid overdose and the approval forms part of the agency’s ongoing efforts to combat the nation’s opioid crisis. Generic injectable naloxone products are already in use at health care settings, but...
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    Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

    In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition. The comment period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others. SDOs, in general...
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    Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal judge scolds Purdue, Endo and Mallinckrodt for stall tactics in opioids case ( Fierce ) ( Law360 -$) 'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst ( Fierce ) Judge rejects challenge of New York City's mandatory measles vaccination order ( Reuters ) Washington State Senate Passes Bill Removing Exemption For Measles Vaccin...
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    DTC Drug Advertising: Study Finds Mixed Impact on Patients, Prescribers

    A new literature review of studies of direct-to-consumer (DTC) prescription drug advertising identifies potential positives and negatives for DTC advertising on the patient-prescriber relationship and highlights gaps in the current medical literature on the topic.   The review, authored by researchers at RTI International and the US Food and Drug Administration (FDA), looked at 38 studies published between 1982 and 2017 that examined outcomes reported by patients, pres...
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    CDRH Draft Guidance Tackles Nitinol Devices

    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices. The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticit...
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    Australia and Canada Jointly Approve Breast Cancer Drug

    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the appr...
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    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
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    Recon: Mustang Bio Soars After Gene Therapy Appears to Cure ‘Bubble Boy’ Patients

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘Bubble Boy’ Biotech Mustang Bio Soars 250 Percent After Cure Announcement ( Bloomberg ) ( Reuters ) ( NPR ) ( Endpoints ) ( NIH ) Pricing is taking a toll on the reputation of the pharmaceutical industry ( STAT ) A biotech startup’s lofty goal: Kill cancer with pills that target RNA instead of proteins ( STAT ) ( Xconomy ) Drugmakers Reveal List Prices Online...
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    EU Regulatory Roundup: Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors   The European Commission has published a document detailing the interplay between clinical trial rules and the General Data Protection Regulation (GDPR). The document sets out the data protection requirements of the incoming Clinical Trials Regulation (CTR) and how they interact with GD...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
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    MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

    MedTech Europe sent an open letter to the European Commission (EC) on Monday to urge immediate action on implementing the new medical device and IVD regulations as the transition is becoming “clearly untenable.” The letter from the trade association’s CEO Serge Bernasconi underscores the growing urgency and need for the EC and member states to finish what they started in 2017 with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). The letter highl...
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    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...