In Brief: FDA testing, FDA inspection creep, Q11 ‘clarified,’ enforcement dashboard, data integrity, more
This article was originally published in The Gold Sheet
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...
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.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.