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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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    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
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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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    CDER Report on Novel Approvals Highlights Firsts in 2017

    2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties. And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER ...
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    Woodcock: CDER Informatics System is Top Priority for 2018

    Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system. Woodcock made the comment at the FDA/CMS Summit in Washington, DC on Tuesday, noting that the rest of CDER's priorities for 2018 will be similar to priorities in 2017. Among those are implementing the 21st Century Cures Act ; working toward the goal...
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    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...
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    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...
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    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...
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    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 ...
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    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...
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    FDA Details Plans for More Efficient Inspections, Facility Evaluations

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...
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    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...