FDA, Industry Still Grappling With 'Consistent-With-Labeling' Guidance
Executive Summary
In June, US FDA gave manufacturers permission to discuss their devices in ways that strayed outside the official labeling language as long as they met certain standards. FDAers and lawyers discussed the practical implications of that rule at a recent conference in Washington DC.
You may also be interested in...
FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details
Two newly finalized guidance documents from US FDA help broaden the scope of acceptable manufacturer communications. One addresses communications with payers, while the other discusses communications that are consistent with approved labeling.
FDA Chief Counsel Addresses First Amendment, Enforcement
US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.