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How Shuren’s Departure from the FDA May Impact the LDTs Rule

How Shuren’s Departure from the FDA May Impact the LDTs Rule

by Tara Cepull, MA | Oct 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.

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LDTs Rule Update: More Support for Legal Challenges Against FDA

LDTs Rule Update: More Support for Legal Challenges Against FDA

by Rachel Muenz | Oct 10, 2024 | News

Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”

Inside the Lab Industry: Q3 Earnings Signal Beginning of the End of ‘COVID-19 Hangover’

Inside the Lab Industry: Q3 Earnings Signal Beginning of the End of ‘COVID-19 Hangover’

by Glenn S. Demby | Jan 4, 2024 | Inside the Lab Industry-lir, Lab Industry Advisor, Premium

What 2023 Q3 earnings from 30 key US lab companies indicate about the current state of the industry and outlook for 2024.

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Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business

Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business

by Glenn S. Demby | Sep 26, 2023 | Earnings-lir, Essential, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.

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Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions

Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions

by Glenn S. Demby | Aug 31, 2023 | Essential, Industry Buzz-lir, Laboratory Industry Report

Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.

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