Search Results for Real-World Evidence

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FDA Used Real-World Evidence in Heart Valve Approval By Michael Mezher - Published 14 June 2017

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.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Sapien 3, Edwards Lifesciences, Real-World Evidence

FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’ By Zachary Brennan - Published 08 December 2016

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."

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: 21st Century Cures, real-world evidence, real-world data and pharmaceuticals

PDUFA VI: Highlights on What to Expect By Zachary Brennan - Published 15 August 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PDUFA, PDUFA VI, real-world evidence, Sentinel, model-informed drug development

FDA Outlines Medical Device Real-World Evidence User Fee Proposal By Zachary Brennan - Published 23 May 2016

Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE).

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance

Tags: MDUFA, Medical Device User Fee Act, real-world evidence and medical devices