• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    NEST Seeks Medical Device Test Cases for Using Real World Evidence

    The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices. Background In 2016, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) awarded a $3 million grant to the Medical Device Innovation Consortium (MDIC) to establish NESTcc. The cente...
  • Regulatory NewsRegulatory News

    Study Uses Real World Evidence to Replicate Pivotal Trial Results

    A study published in JAMA Internal Medicine on Monday was able to replicate the results of a large randomized controlled clinical trial for the blood pressure drug telmisartan using real world evidence gathered from insurance claims data. The goal of the study, which was conducted by researchers at Harvard Medical School, was to investigate whether health care databases can be used to confirm findings from clinical trials conducted to support additional indications for...
  • Regulatory NewsRegulatory News

    Building NEST: New Executive Director, CDRH's Shuren Discuss Plans

    The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go. "NEST is about how we improve the value, use, and time and cost of using real-world data," Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), explained to attendees of AdvaMed’s MedTech conference in San J...
  • Regulatory NewsRegulatory News

    FDA's Woodcock: The Clinical Trials System is 'Broken'

    The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday. The comment came at the end of Woodcock's talk in which she also noted that use of master protocols (ie. protocols for trials that look at multiple therapies in ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) has finalized a slightly tweaked guidance on medical device companies’ use of real-world data (RWD) and real-world evidence (RWE) in winning approvals for their products. FDA says the guidance is meant to explain the "characteristics and sources of RWD and characteristics of RWE that may be sufficient for use in making various regulatory decisions." In addition to the draft guidance, the final guidance includes further clar...
  • Regulatory NewsRegulatory News

    FDA Used Real-World Evidence in Heart Valve Approval

    The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures. In a blog post Wednesday, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren and Bram Zuckerman, director of CDRH's Division of Cardiovascular Devices touted the agency's turnaround from 42nd in the world to approve a TAVR devic...
  • Regulatory NewsRegulatory News

    FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework

    Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions. In an article in Nature Reviews Drug Discovery on Friday, Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside former FDA Commissioner Robert Califf and other high-ranking agency officials, argue ...
  • Regulatory NewsRegulatory News

    FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

    Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." Defining RWE Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, wr...
  • Regulatory NewsRegulatory News

    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
  • Regulatory NewsRegulatory News

    CDRH Outlines Top 10 Science Priorities for 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017. As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as desc...
  • Regulatory NewsRegulatory News

    PDUFA VI: Highlights on What to Expect

    The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development. The meeting follows the July release of the full details of the performance ...