CMS 2005 Stakeholder Meeting To Discuss Future Of CLIA Quality Control
This article was originally published in The Gray Sheet
CMS intends to address diagnostic quality control issues, such as whether FDA will enforce CLIA-related regulations on package inserts, during a March 18, 2005 stakeholder meeting
You may also be interested in...
CLIA-regulated diagnostic manufacturers can change their package inserts and work with labs to take advantage of increased flexibility granted under CMS' new equitable quality control (EQC) testing options
Approved in February as an on-demand remedy, Nurtec will be filed for migraine prevention after success in Phase III. It could be the first oral preventive therapy and first dual purpose migraine drug.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.