Friday, October 14, 2022

Very Brief Blog: in JAMA, Gottlieb & McClellan Promote VALID (FDA Diagnostics Regulation)

As numerous trade journals have reported over several months, the VALID ACT (FDA control of LDT diagnostic tests) has been rising and falling regarding its odds of becoming legislation.

In a new twist, Scott Gottlieb and Mark McClellan, both former heads of the FDA, strongly encourage Congress to pass the VALID ACT and as soon as possible.   (McClellan is a former head of both FDA and CMS).

Find it here:

Among others, AdvaMed is also urging Congress to push ahead with VALID (here).

The Regulatory Affairs Professionals Society, RAPS, hosts a two day course on the new European IVD regulations, October 18-19 in Amsterdam, full agenda here.