HP&M Files Comments Opposing FDA’s Proposed LDT Rule
FDA Law Blog
DECEMBER 6, 2023
The support FDA offers for its proposition – which comes from a mixture of sources, including a few published scientific articles, newspaper stories, FDA’s experience with LDTs with COVID, anecdotes, older case studies, and class action lawsuits – is singularly unconvincing. The proposed rule similarly ignores the benefits of LDTs.
Let's personalize your content