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  • Regulatory NewsRegulatory News

    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS. The guidance, first drafted in June 2016, describes the process and information FDA uses to determine the appropriate classification for a device to be studied. "Importantly, the categorization paradigm has shifted from a more rigid approach ...
  • Regulatory NewsRegulatory News

    FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions

    The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE). FDA says it is seeking comments from stakeholders to inform its review of the proposed template to determine whether the agency will recommend the template as is, or with modifications, for regulatory submissions involving study data. Acc...
  • Regulatory NewsRegulatory News

    Gottlieb Discusses Efficiencies, Opioids, Pricing and More at National Press Club

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took questions at the National Press Club in Washington, D.C. on Friday, offering perspective on what the agency is doing to be more efficient, actions related to the opioid epidemic and how FDA plays a role in the drug pricing debate. In the question and answer section of the talk, Gottlieb noted the agency will be putting forth more guidelines to drive efficiencies in the development of new therapi...
  • Feature ArticlesFeature Articles

    Drug Reimbursement in Canada

    This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place. The Regulatory–Reimbursement Interface Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval from Health Canada. Regulatory proces...
  • Feature ArticlesFeature Articles

    Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

    This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...
  • Regulatory NewsRegulatory News

    Report Highlights Cracks in the Market for Generic Competition

    As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages. The analysis, authored by Ernst Berndt and Stephen Murphy of the Massachusetts Institute of Technology, and Rena Conti from the University of Chicago, reveals...
  • Regulatory NewsRegulatory News

    FDA Warns Phototherapy Device Maker for Quality System Issues

    The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March. The warning letter, dated 11 July 2017, details eight violations, including validation, recordkeeping and equipment calibration issues. FDA also says the company failed to notify it within 10 days of issuing a recall for one of its devices, and did not do so until the...
  • Regulatory NewsRegulatory News

    FDA, NCI to Collaborate Further on Cancer Research

    The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment. "The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technolo...
  • Regulatory NewsRegulatory News

    Cybersecurity: House Committee Looks to Build on Public-Private Partnerships

    The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...
  • Regulatory NewsRegulatory News

    NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

    The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies. The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies. "As genomic sequencing data become mainstream in cancer therapy...
  • Feature ArticlesFeature Articles

    International Medical Device Regulatory Update: News and Views From San Jose

    Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medica...