• Regulatory NewsRegulatory News

    Startups, Small Device Firms in ‘Wait-and-See Mode’ Over Health Canada MDSAP Requirements

    As Health Canada continues to tweak its Medical Device Single Audit Program (MDSAP) with the goal of transitioning ahead of its compliance deadline, several issues facing small- to medium-sized device companies remain unaddressed. The requirement of obtaining a MDSAP certificate for companies to legally sell devices in the Canadian market has triggered a “wait-and-see mode” among those that are smaller, including startups, Christine Zomorodian, principal at Gish Consult...
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    Recon: Bluebird's gene therapy eliminates blood transfusions for some beta-thalassemia patients

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US AstraZeneca's Tagrisso just got the lung cancer nod it needs to hit $3B in sales ( Fierce ) ( Reuters ) ( Endpoints ) ( Business Insider ) FDA staff raises safety concerns over Lilly/Incyte arthritis drug ( Reuters ) ( Endpoints ) ( Bloomberg ) Amgen exec moves to become Novartis CMO ( The Pharma Letter ) ( Endpoints ) ( Fierce ) Novartis CEO feels heat on U.S. g...
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    Abbott Extends Cybersecurity Patch to Implantable Defibrillators

    Abbott has extended the release of a firmware upgrade—applied to 465,000 of its pacemakers last year to patch cybersecurity vulnerabilities—to 11 of its implantable defibrillator device families as part of its phased corrective action plan. According to the US Food and Drug Administration (FDA), the firmware update announced Tuesday was approved 11 April for the implantable cardioverter defibrillators (ICDs) as well as the cardiac resynchronization therapy defibrill...
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    Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Has biopharma over-invested in cancer R&D? ( Novartis Institutes for Biomedical Research ) GSK flags pharma M&A ambitions by poaching Roche deal-maker ( Reuters ) ( Fierce ) ( Endpoints ) Ultragenyx wins a blockbuster OK for its leading rare disease drug burosumab — priced at $200,000 ( Endpoints ) ( Fierce ) ( FDA ) Rigel bags first FDA approval ( PharmaTimes ) ...
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    FDA Considers National ICD Registry for Real-World Evidence

    As part of a demonstration project launched via the National Evaluation System for health Technology Coordinating Center (NESTcc), the US Food and Drug Administration (FDA) is considering a national registry for implantable cardiac defibrillators (ICDs) to expand on its use of real-world evidence (RWE). “This is a project that has been going on for more than a year, and very recently it got adopted by the NESTcc,” Gregory Pappas, associate director for National Device S...
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    Recon: Merck and Bristol-Myers Offer Positive Lung Cancer Data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Merck Keeps Edge Over Bristol-Myers In Cancer Duel ( Forbes ) ( WSJ ) ( CNBC ) ( FT -$) ( NY Times -$) ( Bloomberg ) ( Press ) AZ’ Tagrisso offers sustained benefit in lung cancer ( PharmaTimes ) ( PMLiVE ) ( pharmaphorum ) FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma ( FDA ) ( MSKCC ) ( OncLive ) ...
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    Health Canada Eases Requirements for MDSAP Transition

    In response to medical device manufacturers facing audit scheduling challenges, Health Canada announced Friday a policy turnabout in requirements for transitioning to the Medical Device Single Audit Program (MDSAP). Manufacturers will be required to submit MDSAP certificates by 31 December 2018 to legally sell devices in the Canada market. However, Health Canada has now decided not to take enforcement actions against manufacturers without these certificates if they demo...
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    Recon: Mylan Seeks to Buy Merck KGaA’s Consumer Health Business

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US For Cancer Drugs, Will Monday's Data Be As Good As It Gets? ( Forbes ) ( EP Vantage ) FDA acts to pull concentrated caffeine from market ( NBC News ) ( MedPage Today ) ( CNBC ) Rite Aid Sees 'Mid-Sized Market' Future For Its PBM ( Forbes ) ( WSJ ) ( Reuters ) New Jersey jury hits BD subsidiary Bard with $33m pelvic mesh verdict ( MassDevice ) ( Law360 -$) Pfizer...
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    Health Canada to Increase Device Postmarket Surveillance, Create New Digital Health Division

    The medical device space in Canada will see a wave of regulatory changes, with modifications to post-market surveillance regulations and the creation of a new premarket review approach for digital health technologies proposed this week. As part of a five-year initiative aimed at improving the regulatory review of drugs and devices, Health Canada released two notices of intent on Tuesday, including plans to establish a new division within the Therapeutic Products Directo...
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    FDA Proposes New Option for Device Companies to Apply for 510(k) Clearance

    A draft guidance the US Food and Drug Administration (FDA) revealed Wednesday sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing firms greater flexibility. By expanding the previously established Abbreviated 510(k) program, the new option will “modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new ...
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    Recon: CVS Tool to Combat Drug Prices, Alexion Inks $855M Deal to Buy Wilson

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US CVS To Compare Drug Prices At The Pharmacy Counter ( Forbes ) ( CNBC ) ( The Washington Post ) Pfizer's Inlyta misses mark in Phase 3 kidney cancer study ( BioPharma Dive ) ( PMLiVE ) ( Fierce ) Cellectis raises $164M for CAR-T and gene-editing programs ( Fierce ) ( Endpoints ) Novartis’ Afinitor Disperz wins new TSC-related approval ( PharmaTimes ) ( The Pharma ...
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    FDA Fleshes Out Guidance on Pediatric Drug Development with New ICH Addendum

    The US Food and Drug Administration (FDA) adopted its version of the International Council for Harmonization’s (ICH) addendum on pediatric drug development, with a substantial amount of new information added to the policy principles initially set forth in 2000. The agency’s guidance—released Tuesday and based on the August 2017 version of ICH’s E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population—updates the 2000 version to reflect ...