Day: May 30, 2024

This week the FDA released its “Platform Technology Designation Program” to formally recognize well-understood and reproducible technologies in FDA-approved drugs or biologics that could be used for future product development and approvals. It is important to understand the difference between this and the cross-referencing process used commonly to leverage previously submitted information for new applications.  … Read more

As expected and promised, the FDA got sued this week for the new LDT Rule. In its latest attempt to regulate Lab Developed Tests (LDT), the FDA designated all such tests as conventional in vitro diagnostic (IVD) tests that require registration and formal approval or clearance by the FDA as a medical device. The lawsuit … Read more