Senators Urge OMB to Release FDA’s Draft Guidance on LDTs


Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several years.”

While FDA has hinted in the past that it was developing or had developed a “risk based” approach to LDT regulation, this is the first confirmation for me that

such a guidance has already been drafted, and that it is in fact out of FDA’s hands (and apparently has been for a long time now).

The White House seems not to share FDA’s position on LDT regulation. It would be interesting to know if negotiation is going on between the White House and FDA for modifications to the draft guidance.

Fierce wrote a nice summary of the letter and its implications.

Read the letter to OMB.







Real-Time COVID R&D Tracking

As COVID-19 infections continue to spread, organizations with technologies or devices that can support new drug, vaccine, or test development have a life-saving contribution to make. The Amplion Intelligence Platform can alert you to new COVID-19 trial activities in real-time and automatically match you to partners who need your unique capabilities immediately. It’s already tomorrow somewhere, so let us help you start today.  Learn More

Request Access