Search Results for real world evidence

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NEST Seeks Medical Device Test Cases for Using Real World Evidence By Zachary Brennan - Published 05 December 2017

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.

Categories: News, US, FDA, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NEST, NESTcc, real world data, real world evidence

Study Uses Real World Evidence to Replicate Pivotal Trial Results By Michael Mezher - Published 20 November 2017

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.

Categories: News, US, FDA, Drugs

Tags: Real World Evidence

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

Real World Evidence: FDA Commits to Advancing its Use By Zachary Brennan - Published 19 September 2017

To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: real world evidence, Scott Gottlieb, clinical data

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

ICH Looks to Revamp GCP Guidelines, Adds New Members By Michael Mezher - Published 17 November 2016

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.

Categories: News, Anvisa, ICH, MFDS, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: ICH, International Council for Harmonisation, Good clinical practice, GCP, Real world evidence

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

New Report Calls on FDA to Clarify Use of Real-World Evidence By Zachary Brennan - Published 23 June 2016

As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: real world evidence, FDA Commissioner, Robert Califf, Patrick Soon-Shiong, Duke University

Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA By Michael Mezher - Published 11 May 2016

The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week.

Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: Real world evidence, Sentinel, Robert Califf, FDLI

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