• Regulatory NewsRegulatory News

    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the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents identifying performance criteria and testing methodologies for certain devices within four class II device types.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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: FDA Panel Backs GSK's OTC Nicotine Spray; Swiss Competition Watchdog Raids Makers of Stomach Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs ( STAT ) GSK's over-the-counter nicotine oral spray gets FDA panel backing ( Reuters ) Ginkgo Bioworks scores an eye-popping valuation with latest fundraise ( STAT ) Insys Bankruptcy Plan Comes Up Short in Paying Justice Department ( WSJ ) Bristol jo...
  • Regulatory NewsRegulatory News

    Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...
  • Regulatory NewsRegulatory News

    FDA Lays Out Tech Modernization Action Plan

    As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US Food and Drug Administration (FDA) on Wednesday unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FD...
  • Regulatory NewsRegulatory News

    Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the safety of currently available treatments or diagnostics but are used for morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices that may be included in this Safer Technologies Program” or “STeP” may include t...
  • Feature ArticlesFeature Articles

    Breaking Down UDI Questions

    This article answers questions and clears up ambiguities related to the Unique Device Identification (UDI) system developed for medical devices related to US and European Union (EU) regulations. The author presents an in-depth discussion of terms including base package, unit of use, packaging levels, UDI databases, accessories and spare parts, UDI ownership and scanning versus verifying. She also looks at UDI development outside of the US and EU.   Introduction   ...