How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
What 2023 Q3 earnings from 30 key US lab companies indicate about the current state of the industry and outlook for 2024.
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.