Members of Congress Urge Obama Administration to Release FDA Draft Guidance on LDT Regulation | GenomeWeb

NEW YORK (GenomeWeb News) – Nine Democratic members of Congress are urging the Obama Administration to release a US Food and Drug Administration draft guidance on the regulation of laboratory-developed tests.

In a letter to Sylvia Mathews Burwell, the director of the Office of Management and Budget, the legislators said, "We have reached a critical point in the development of advanced diagnostics at which it has become essential that FDA move this guidance forward to ensure appropriate and efficient oversight of safe and effective diagnostics."

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.