European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017)
By Nick Paul Taylor -
Published 18 May 2017
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs
Tags: European Regulatory Roundup, EU roundup of pharma news, Aspen, personalized medicine, ANSM
Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics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The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it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 Regulation and Personalized Medicine
By Rachelle D'Souza -
Published 22 January 2016
This article discusses examples of personalized medicine in industry as well as examples of FDA regulatory activities with respect to personalized medicine.
Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Labeling, Postmarket surveillance, Regulatory strategy, Research and development, Submission and registration
Tags: Personalized Medicine
New Regulatory Approaches Key to Future of Personalized Medicine
By Zachary Brousseau -
Published 13 May 2015
While full realization of the potential of personalized medicine may yet be years off, it already is beginning to pose new challenges for both regulators and those involved with developing and marketing personalized medicine and companion diagnostic products.
Categories: HTML, Articles, Under RAPS, RAPS Events, Europe, RAPS, In vitro diagnostics
Tags: personalized medicine, precision medicine, personalised medicine, EU, EMA, FDA
House Committee Unveils Intent to Overhaul FDA Regulatory Framework
By Alexander Gaffney, RAC -
Published 01 May 2014
Categories: US, FDA
Tags: Diana DeGette FDA, Fred Upton FDA, 21st Century Cures Initiative, House, Latest News, Congress, personalized medicine
Trends in Personalized Medicine
By Alexander J. Varond -
Published 30 October 2013
As decades of experience have shown, drugs can work very differently in different individuals. This article surveys recent trends and developments in personalized medicine, FDA's current stance and new challenges facing industry.
Categories: Features, US, FDA, CDER
Tags: Lab-Developed Tests, LDTs, personalized medicine, IVD
FDA Says Focus on Regulatory Science Key to Advancing Personalized Medicine and Helping Patients
By Alexander Gaffney, RF News Editor -
Published 29 October 2013
Categories: US, FDA
Tags: Report, Approvals, Latest News, regulatory science, personalized medicine
Supreme Court Considers Personal Medicine Patent
Published 08 December 2011
The Supreme Court considered a major patent case last week that asked whether observed correlations between drug dosages and medical treatment were subject to patent protection.
Categories: Regulatory intelligence
Tags: Prometheus Laboratories, Patent, Supreme Court, medicine, personalized medicine