In Brief: FDA testing, FDA inspection creep, Q11 ‘clarified,’ enforcement dashboard, data integrity, more
This article was originally published in The Gold Sheet
Executive Summary
FDA posts testing results; regulatory creep knocks at door; ICH Q11 ‘clarified’ for Europe; FDA’s new enforcement dashboard; data integrity insights; FDA’s Arista challenges India; FDA’s new quality platform.
You may also be interested in...
What Not To Do When An FDA Inspector Comes Knocking At Your Door
FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.
Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier
To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.