FDA Accepts Feedback On VALID, Clinical Lab Test Lobby Encouraged

American Clinical Laboratory Association (ACLA) president and CEO Julie Khani said she looks forward to starting a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics. Specifically, she hopes to work with the agency on revisions to the bill's provision involving precertification and modification of existing tests in order to make those concepts less burdensome for test makers. Khani’s comments followed a speech by FDA Chief of Staff Lauren Silvis...