Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors
June 26th, 2017
A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
May 24th, 2017
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
Reference Viral DataBase v10.2
May 23rd, 2017
New in May 2017, the NGS Reference Virus Database version 10.2 (unclustered and clustered)
Optimizing regulatory oversight for Next Generation Sequencing tests
July 6th, 2016
In support of the White House’s Precision Medicine Initiative, the FDA issued two draft guidances that offer a streamlined approach to the oversight of ‘Next Generation Sequencing’ tests that detect medically important differences in a person’s genomic makeup.