FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies
The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.
New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
Jun 22, 2018
Feb 15, 2018
ACLA Seeks Summary Judgment in PAMA Lawsuit
Dec 11, 2017
ACLA Files Lawsuit Challenging PAMA Rates
Sep 28, 2017
Jan 17, 2017
Mar 29, 2016