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What Labs Need to Know About Reporting Adverse Events to the FDA

What Labs Need to Know About Reporting Adverse Events to the FDA

by Tara Cepull, MA | Nov 1, 2024 | Compliance Perspectives-lca, Compliance-lca, Essential, FDA-lca, Lab Industry Advisor

Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events

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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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Fighting the FDA’s Final Rule on LDTs

Fighting the FDA’s Final Rule on LDTs

by Michael Schubert, PhD | Oct 28, 2024 | Essential, FDA-lca, Lab Industry Advisor, LDTs-lir, Legislation-lca, Top of the News-lir

CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.

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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”

Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data

Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data

by Scott Wallask | Sep 5, 2024 | Essential, Industry Buzz-lir, Lab Industry Advisor

Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists

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