Search Results for real world data

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Building NEST: New Executive Director, CDRH's Shuren Discuss Plans By Zachary Brennan - Published 27 September 2017

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.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: NEST, real world data, Jeff Shuren

FDA's Woodcock: The Clinical Trials System is 'Broken' By Zachary Brennan - Published 20 September 2017

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.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Government affairs

Tags: Janet Woodcock, real world evidence, real world data, drug development

FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions By Zachary Brennan - Published 30 August 2017

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.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: real world evidence and medical devices, real world data and FDA

EMA to Continue Adaptive Pathways Program as Pilot Ends By Zachary Brennan - Published 03 August 2016

The European Medicines Agency (EMA) on Wednesday published a final report on its experience from its adaptive pathways pilot project, noting that a few aspects of the program need to be further improved and refined moving forward.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: adaptive pathways, EMA pilot project, Blue, gene therapy, real world data

FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: real-world data, device and real world evidence, device registries, FDA guidance on real world data

Real World Evidence: Can it Support New Indications, Label Expansions? By Michael Mezher - Published 10 March 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Postmarket surveillance, Regulatory strategy

Tags: Real world evidence, RWE, Real world data, Janet Woodcock, Robert Temple, Sentinel