Search Results for Precision Medicine

Showing 1 – 17

International Medical Device Regulatory Update: News and Views From San Jose By Randolph Fillmore - Published 20 December 2016

Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Categories: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

FDA, EMA Officials: Regulators Must Adapt to Effectively Regulate Precision Medicine By Michael Mezher - Published 14 October 2016

In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, say top officials at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as the former chair of the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

Categories: News, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Regulatory strategy

Tags: Precision medicine

For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’ By Zachary Brennan - Published 03 October 2016

The US Food and Drug Administration (FDA) on Monday launched what it’s calling an “App-a-Thon,” inviting software developers to get together and add next-generation sequencing (NGS) software apps to the precisionFDA app library.

Categories: News, US, CDRH, Biologics and biotechnology, In vitro diagnostics, Project management

Tags: precisionFDA, NGS applications, precision medicine

FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics By Zachary Brennan - Published 14 July 2016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the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.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

Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative By Zachary Brennan - Published 07 July 2016

New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Preclinical, Quality

Tags: Precision Medicine Initiative, next gen sequencing, DNA technologies

Regulating Precision Medicine: Capacity vs. Overreach By Zachary Brennan - Published 05 May 2016

As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine.

Categories: News, Oceania, US, FDA, Biologics and biotechnology, Combination products, Drugs, Ethics, Government affairs

Tags: precision medicine, regulating DTC genomic tests, 23andMe

Precision Medicine: Technology, Regulations and Challenges By Chitra Edwin, PhD, RAC - Published 11 March 2016

This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare.

Tags: Precision medicine, Precision medicine initiative, PMI, Next generation sequencing

Precision Medicine: Technology, Regulations and Challenges By Chitra Edwin, PhD, RAC - Published 11 March 2016

This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare.

Categories: Features, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy, Reimbursement

Tags: Precision medicine, Precision medicine initiative, PMI, Next generation sequencing

Tufts Outlines Regulatory Initiatives to Spur Innovation in 2016 By Zachary Brennan - Published 08 January 2016

Further harmonization among major regulatory agencies globally will look to focus on pediatric drug studies in 2016, according to a new report from the Tufts Center for the Study of Drug Development.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Tufts CSDD, pediatric studies, precision medicine, Sentinel

precisionFDA Launches to Help With NGS Assay Validation, Data Sharing By Zachary Brennan - Published 15 December 2015

In the spirit of sharing, the US Food and Drug Administration (FDA) on Tuesday launched precisionFDA, a new online, cloud-based platform where genomics experts from industry, academia, government and elsewhere can come together and securely share data on next-generation sequencing (NGS).

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Due Diligence, Ethics, In vitro diagnostics

Tags: NGS, next-generation sequencing, NGS assay validation, precisionFDA, precision medicine

FDA Officials Review Algorithms Used for NGS Analysis By Michael Mezher - Published 01 December 2015

A group of scientists from the US Food and Drug Administration's (FDA) Division of Bioinformatics and Biostatistics have reviewed the algorithms used to align the data generated by next-generation sequencing (NGS) tests to reference genomes.

Categories: News, US, FDA, In vitro diagnostics, Research and development

Tags: Next-generation sequencing, NGS, precision medicine, Division of Bioinformatics and Biostatistics

Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards By Michael Mezher - Published 12 November 2015

Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics.

Categories: FDA, Government affairs, In vitro diagnostics, Regulatory strategy

Tags: Precision Medicine Initiative, Next-Generation Sequencing, NGS, Design Concept Standards, Performance Standards

FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation By Zachary Brennan - Published 21 September 2015

The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board.

Categories: News, US, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: FDA Science Board, Science Looking Forward Subcomittee, US FDA, precision medicine, 21st Century Cures

FDA Looks to Develop Regulatory Strategies for Genomic Testing By Michael Mezher - Published 08 September 2015

To further the president's Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing (NGS) technologies.

Categories: News, US, FDA, In vitro diagnostics, Regulatory strategy

Tags: precision medicine initiative, next generation sequencing, NGS

precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine By Michael Mezher - Published 06 August 2015

The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies.

Categories: News, US, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy

Tags: Precision medicine, openFDA, precisionFDA, Office of Health Informatics, NGS, Next generation sequencing

FDA: What's Slowing Progress in Some Disease Areas? By Michael Mezher - Published 17 July 2015

In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology.

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

Tags: Precision Medicine, Biomarkers, Surrogate Endpoints, HCV, Alzheimer's, Robert Califf

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