Search Results for companion diagnostics

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EMA Lays out Plans for Companion Diagnostic Guideline By Michael Mezher - Published 28 July 2017

The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines.

Categories: News, Europe, EMA, In vitro diagnostics

Tags: Companion Diagnostics, CDx, Precision Medicine, Biomarkers

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics By Zachary Brennan - Published 14 July 2016

The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, In vitro diagnostics, Manufacturing

Tags: precision medicine, companion diagnostics, IVDs, therapeutic, genetic tests

Regulatory Perspectives on Companion Diagnostics By Philipp Novales-Li, DMedSc, PhD, DPhil, RAC - Published 09 October 2013

Companion diagnostics offer a revolutionary approach for redefining the traditional fields of pharmacology and disease diagnostics. This article covers recent developments in regulatory science related to companion diagnostics.

Categories: Features, FDA, Medical Devices

Tags: IVDs, companion diagnostics

A Push to Tie New Drugs to Testing Published 26 December 2011

Categories: FDA, Drugs, Regulatory intelligence

Tags: companion diagnostics, diagnostics