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Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics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The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it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FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics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the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.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