• Feature ArticlesFeature Articles

    Contingency Plans for MDR and IVDR Implementation for a no Deal Brexit

    This article discusses implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) regarding the potential exit (called Brexit) of the United Kingdom (UK) from the European Union (EU). The author suggests the fate of regulations will be not without consequence should the UK and the remaining members of the EU find they are unable to negotiate how medical devices will be regulated, sold and moved between the UK and t...
  • Regulatory NewsRegulatory News

    FDA Consults on Abuse-Deterrent CNS Stimulants

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation to gather input on the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system (CNS) stimulants.   The agency also says it is seeking comments on whether such formulations could help to reduce prescription stimulant misuse and abuse.   According to FDA, most currently marketed prescription CNS stimulants are amphetamine salts and other similar compo...
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    EMA's CHMP Recommends Three New Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.   The newly recommended medicines include Astellas' acute myeloid leukemia drug Xospata (gilteritinib), which was granted orphan designation and was reviewed under EMA's accelerated assessment program. The recommendation comes l...
  • ReconRecon

    Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Campaign After Polio Reemerges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi Unveils Plan to Lower Prescription Drug Prices ( Focus ) US House speaker: Drug pricing plan should be priority for White House ( Reuters ) Democrats' drug pricing proposal 'dead on arrival' in Senate: leading Republican ( Reuters ) ( Politico ) Trump says he likes a Republican drug bill after Democratic alternative unveiled ( Reuters ) How An 'Interna...
  • Regulatory NewsRegulatory News

    First MDR Certificate Issued for Class III Device

    Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system. The newly certified device is Biotronik’s Renamic programmer software , which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchro...
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    CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway

    As part of work to implement the optional Safety and Performance Based Pathway for medical devices, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents identifying performance criteria and testing methodologies for certain devices within four class II device types. CDRH also released updated final guidance explaining the new pathway and to further clarify the information FDA wil...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...
  • Regulatory NewsRegulatory News

    Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition

    A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping. Product hopping, which involves companies reformulating drugs to restrict competition, can include many different types of reformulations, such as a change from a capsule to a tablet, a change in dosing or strength or a reformulation to an ext...
  • Feature ArticlesFeature Articles

    Impact of Regulation 2017/745 (MDR) on the Relationship Between Medical Device Manufacturers and Their Suppliers and Subcontractors

    This article highlights the imminent regulatory challenges posed by the European Union’s (EU) Medical Devices Regulation (MDR) 2017/745. The authors propose a “balanced approach” for maintaining compliant supplier quality agreements for the new regulatory landscape. The authors assess the impact of EU MDR, cover the implications for quality agreements between medical device manufacturers and suppliers and discuss strategies for legal manufacturers achieving compliance with...
  • Regulatory NewsRegulatory News

    Pelosi Unveils Plan to Lower Prescription Drug Prices

    As Sen. Chuck Grassley (R-IA) continues to push his own competing drug pricing legislation in the Senate, House Speaker Nancy Pelosi (D-CA) unveiled her proposal to lower prescription drug prices on Thursday, with a plan likely to please more liberal Democrats and further distance Republicans. At the heart of Pelosi’s plan is the idea to allow Health and Human Services Secretary Alex Azar to select between 25 and 250 drugs annually and directly negotiate with manufactur...
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    FDA Develops Tool to Simulate Immune Response to Biologics

    Researchers at the US Food and Drug Administration (FDA) have developed a new computational tool to predict whether the body will mount an immune response that blocks the activity of biological drugs.   Specifically, the tool, dubbed TCPro, simulates how the body's CD4+ T cells will respond to biotherapeutics, and predicts whether the body will produce anti-drug antibodies.   "TCPro can be used to assess the potential for antibody formation even before the laborato...
  • Regulatory NewsRegulatory News

    FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers

    The US Food and Drug Administration (FDA) is calling on drug compounders to be more diligent with their suppliers to ensure that bulk active pharmaceutical ingredients (API) they receive have been tested and properly handled throughout the supply chain.   "The agency urges compounders to know your bulk supplier and know if they are testing the drugs before you purchase bulks for patient use," FDA writes.   The advisory comes after drug repacker Darmerica LLC last w...