Valid Act News Today

The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products...

United States Congressman Jake Ellzey joined Republican colleagues in signing legislation which would require a valid form of identification in order to board a commercial flight to the United States.

A proposed regulatory shift has injected uncertainty into the laboratory-testing market just as startups are advancing an array of tests to detect diseases sooner and personalize treatments.

Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agency’s proposed review.