Video of Congressional Hearing on LDTs Posted Online; FDA Defends Regulatory Authority

by

The video coverage of the September 9 House Energy and Commerce Health Subcommittee hearing regarding the FDA’s intention to issue draft guidance on laboratory-developed tests has been posted online t house.gov.

Among key discussion points was FDA’s authority to regulate LDTs.

Rep. Michael C. Burgess (R-Texas) and other Republicans asked Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), if FDA was able to bypass the formal rulemaking process. Shuren defended FDA’s authority in this regard, and also stated that the draft guidance would be released within 30 days.

PageLines

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