• Feature ArticlesFeature Articles

    Considerations for Development and Implementation of a Companion Diagnostic

    This article discusses four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.   Introduction   The drug development process in the US is extremely long and costly. It is critical to get the patient a drug that is going to work for them. Especially in the oncology space, drugs for the most part are extremely toxic to the patient. Therefore, not only is th...
  • Regulatory NewsRegulatory News

    Final ALS Drug Development Guidance Coming Soon

    Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless on Thursday announced that the agency would finalize guidance on developing treatments for amyotrophic lateral sclerosis (ALS) by the end of September. The 9-page draft guidance, first released in February 2018 , incorporated parts of a draft guidance put together by the ALS Association, known for its viral "ice bucket challenge," which FDA said provided the agency "with scientific advice and insig...
  • Regulatory NewsRegulatory News

    CDRH Details Top Regulatory Science Priorities

    In a report released Thursday, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) outlines its top ten regulatory science priorities.   The top ten regulatory science priorities for the center are:   Leverage “big data” for regulatory decision-making Modernize biocompatibility and biological risk evaluation of device materials Leverage real-world evidence and employ evidence synthesis across multiple domains in regulato...
  • ReconRecon

    Recon: Gilead to Challenge US Patents on Truvada; NICE Chief to Step Down

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to challenge US patents on HIV drug Truvada ( Financial Times ) ( STAT ) ( Bloomberg ) Trump administration appeals drug price disclosure ruling ( The Hill ) ( Reuters ) Retrophin scraps nervous system disorder study, shares dive ( Reuters ) ( Endpoints ) Biotech leaders rally behind Chinese scientists in US, calls for 'measured' policies in wake of pur...
  • Regulatory NewsRegulatory News

    Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance

    With a new pilot project, the Danish Medicines Agency (DKMA) is looking to aid device startups and small- to medium-sized manufacturers (SMEs) comply with the EU’s Medical Devices Regulation (MDR). The pilot project will offer guidance on the new regulatory requirements and run from 15 August through the end of 2019, though the regulator will revisit this timeline for a potential continuation. The agency says it “has experienced increasing demand” from medical device...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 22 August 2019 to include: AstraZeneca purchased Sobi's PRV for $95 mill...
  • Regulatory NewsRegulatory News

    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...
  • RoundupsRoundups

    EU Regulatory Roundup: MHRA Expands Guidance on Assistive Technology to Help Device Industry

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Expands Guidance on Assistive Technology to Help Device Industry   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on assistive technologies, products that support people with disabilities, restricted mobility or other impairments.   MHRA published guidance on the definition and safe use of assistive te...
  • Regulatory NewsRegulatory News

    Former FDA Commissioners Seek to Expand Use of RWE in Regulatory, Payment Decisions

    A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world evidence (RWE) in regulatory and payment decision-making.   The report comes less than a year after the US Food and Drug Administration (FDA) released its Framework for FDA’s Real-World Evidence Program .   “Real-world evidence generated from the application of appropriate research methods and analysis of data derived from clinical, claims, and patient-facing sof...
  • Regulatory NewsRegulatory News

    Industry Criticizes EC’s Specifications for Reprocessing Single-use Devices under EU MDR

    The European Commission’s (EC) draft implementing act on the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR) received criticism in newly posted comments from industry groups. The comments raise issues and concerns with many of the provisions that the draft implementing act for common specifications (CS) on single-use devices set forth in July. The draft implementing act is the second implementing act to be issued in accordance...
  • Regulatory NewsRegulatory News

    Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

    As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do. Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasin...
  • ReconRecon

    Recon: Philips Under Investigation for Graft in Brazil; Pfizer Invests $500M in NC Gene Therapy Facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer invests $500 million in expanding gene therapy facility ( Reuters ) ( Endpoints ) ( Press ) FDA on Novartis data manipulation controversy: ‘We happened to be lucky’ ( STAT ) Apple health team faces departures as tensions rise over differing visions for the future ( CNBC ) Exclusive: Federal scientists urged public warning on opioids in 2006 ( Politico )...