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  • Regulatory NewsRegulatory News

    CDRH Talks Up Timeliness of NEST

    Members of the committee governing the National Evaluation System for health Technology Coordinating Center (NESTcc), including US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, touted the timeliness of NEST in a commentary in Clinical Pharmacology & Therapeutics on Tuesday. Shuren and NESTcc executive director Rachel Fleurence explain how the time for NEST has now come as certain “characteristics of medical ...
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    CDER Looks Ahead at Real World Evidence

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday held a webinar reviewing the agency’s real-world evidence (RWE) framework, which deals primarily in the postmarket space for drugs and biologics. The agency  unveiled  its RWE framework last December to provide a high-level view of how it is looking at the use of real-world data. Jacqueline Corrigan-Curay, director of the Office of Medical Policy within CDER, explaine...
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    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
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    FDA Flags Higher Death Rates Linked to Use of Abiomed Heart Pump in Post-approval Study

    A temporary heart pump manufactured by Massachusetts-based Abiomed prompted a US Food and Drug Administration letter to health care providers on Monday over an increased rate of mortality. The letter cites interim results from Abiomed’s January report on a post approval study (PAS) that was mandated by the agency as a condition for the 2017 FDA approval of the Abiomed Impella RP System. “A total of 44 out of 60 patients (73.3%) survived to 30 days post device explant...
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    NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

    The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday. The committee governing the NEST Coordinating Center (NESTcc) approved a four-pronged 2019 action plan, which involves two “key areas” in which NESTcc “has refined its direction.” These relate to developing the NESTcc data network and planning for the center’s own sustainability. ...
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    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
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    Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

    The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.   The new goal to propel the safety action plan— released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA...
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    FDA Proposes New Framework on Prescription Drug-Related Software

    The US Food and Drug Administration (FDA) issued a request for comment on Monday that sets forth a proposal for a new framework on the regulation of software applications for use with one or more prescription drug products.   The agency’s newly adopted digital health approaches “are still in their early stages,” FDA Commissioner Scott Gottlieb said Monday in remarks at the Reagan Udall Foundation annual public meeting. “A lot of these technologies haven’t advanced as...
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    NESTcc Selects 8 RWE Test Cases for Medical Devices

    The National Evaluation System for health Technology Coordinating Center (NESTcc), which is mutually funded by the US Food and Drug Administration (FDA) and industry, announced Monday it has selected a total of eight real-world evidence (RWE) test cases to evaluate medical device performance in clinical settings.   NESTcc based its selections on applications medical device manufacturers submitted in January under a public call for concepts initiated last year and s...
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    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...
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    Real World Evidence: Can it Support New Indications, Label Expansions?

    At a public workshop in Washington, DC last week, top US Food and Drug Administration (FDA) officials and other experts explored the challenges and opportunities surrounding real world evidence (RWE) in regulatory decision making. The question they sought to answer is whether data gathered from healthcare systems can be used to supplement or support regulatory decisions, such as the approval of new indications or label expansions for existing drugs. FDA currently uses r...