"We Should Have Acted Sooner" On DTC Gene Tests, CDRH Director Shuren Tells Lawmakers
This article was originally published in The Pink Sheet Daily
Executive Summary
Pathway's decision to sell its saliva collection kits at Walgreens stores was the catalyst for the Center for Devices and Radiological Health's current efforts to regulate DTC genetic test services, Shuren told lawmakers.
You may also be interested in...
FDA To Regulate Direct-To-Consumer Genetic Tests
Citing the need to prove that direct-to-consumer genetic assays are analytically and clinically accurate, CDRH sent letters to five genetic testing firms June 10 requesting pre-market submissions for the companies' already-marketed services
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.