Stay updated with breaking news from Verifying Accurate. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final...
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 creates uncertainty in the future of innovation and patient care.”
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead...
Hi, I'm Greg Levine, head of the life sciences regulatory and compliance practice group in Ropes & Gray's Washington, D.C. office.
On October 31, FDA will be offering a webinar on its proposed rule "Medical Devices; Laboratory Developed Tests."