Search Results for NGS

Showing 1 – 13

CDRH Looks Ahead to Priorities for 2018 to 2022 By Zachary Brennan - Published 17 January 2018

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: novel devices, UDI, NGS

FDA Announces Third-Party Review Pathway for Tumor Profiling Tests By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Next-Generation Sequencing, NGS, Tumor Profiling Tests, MSK-IMPACT, New York State Department of Health, NYSDOH

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FDA Issues Draft Guidance on NGS Sequencing for Infectious Disease Diagnostics By Michael Mezher - Published 12 May 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases.

Categories: News, US, FDA, Clinical, In vitro diagnostics

Tags: NGS, Next generation sequencing, Draft Guidance

FDA Discusses How to Regulate NGS Tests for Cancer Diagnoses By Michael Mezher - Published 26 February 2016

The US Food and Drug Administration (FDA) is seeking input on how to regulate next-generation sequencing (NGS) tests that can scan a tumor's genes to guide cancer treatments.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Labeling, Regulatory strategy, Submission and registration

Tags: Next-generation sequencing, NGS, Oncology panels, Public workshop

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

NGS Altering the Landscape of Antiviral Drug Resistance Analysis, FDA Officials Say By Zachary Brennan - Published 20 November 2015

As next-generation sequencing (NGS) costs gradually decline, the Food and Drug Administration’s (FDA) Division of Antiviral Products (DAVP) anticipates that more companies will make the switch to NGS for future antiviral drug resistance analyses and other additional uses.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy

Tags: next-generation sequencing, NGS, FDA, HIV drugs, antiviral drugs, gene sequencing

FDA Looks to Curate Genetic Databases to Support NGS Validation By Michael Mezher - Published 13 November 2015

Experts met at the US Food and Drug Administration (FDA) today to discuss how curated databases could be used to establish the clinical relevance of genetic variations, and how the agency could use these databases to evaluate next-generation sequencing (NGS) diagnostics.

Categories: News, US, CDRH, In vitro diagnostics, Regulatory strategy, Research and development

Tags: Next-generation sequencing, NGS, Database curation

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 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

GHTF Proposes New Harmonization of Medical Device Audits By Alexander Gaffney - Published 24 April 2012

Categories: GHTF

Tags: NGS, RAEIF, Nonconformity Grading System, QUality Management System, SG3(PD)/N19, SG3, Standard, Latest News, QMS, proposed, medical device