Pathology News Roundup: September 4, 2024
Battle Over FDA's LDT Rule Continues. The Association for Molecular Pathology (AMP) has filed a lawsuit against the FDA, challenging the Final Rule...
CAP Pushes HHS to Revoke FDA LDT Regulation. The College of American Pathologists (CAP) is calling on the Department of Health and Human Services (HHS) to terminate the laboratory-developed test (LDT) oversight regulation by the Food and Drug Administration (FDA).
The CAP has opposed the FDA rulemaking and advocated for the administration to rescind the rulemaking by citing significant concerns over extraordinary costs and regulatory burdens on laboratories.
“After the FDA proposed and finalized its rulemaking on the oversight of LDTs, pathologists and their laboratories objected to the arbitrariness and significant costs the new rule imposed on the development of these lifesaving tests,” said CAP President Donald Karcher, MD, FCAP. “Now is the time for the FDA to pull back a regulation that adversely impacts laboratories and their ability to develop and provide these innovative tests for our patients. We urge the administration to act before the first stage of the rulemaking takes effect on May 6.”
President Trump signed the executive order Unleashing Prosperity Through Deregulation on January 31 to eliminate unnecessary regulatory burdens. The FDA LDT oversight rulemaking continues to cause laboratories to reevaluate the LDTs they can offer to patients. The CAP has urged the administration to rescind the rulemaking in a February 14 letter to new HHS Secretary Robert Kennedy and a January 21 communication to President Trump’s transition team.
USCAP 2025. It's almost March -- and that means it's almost time for the The United States and Canadian Academy of Pathology (USCAP) Annual Meeting.
USCAP 2025 is the world's largest gathering of pathologists, offering a platform for professionals to engage with groundbreaking research, learn from esteemed experts, and network with peers. The 2025 meeting is scheduled for March 22–27 at the Boston Convention and Exhibition Center in Boston, MA.
Pathologists attending this event can benefit from a diverse array of educational opportunities, including:
For more details and registration information, visit the official USCAP Annual Meeting website.
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Battle Over FDA's LDT Rule Continues. The Association for Molecular Pathology (AMP) has filed a lawsuit against the FDA, challenging the Final Rule...
Power List 2024. The Pathologist magazine released its 2024 Power List, celebrating the inspirational figures behind innovation and achievement in...
Article Touts Generative AI in Pathology. Generative artificial intelligence (GAI) is emerging as a powerful tool across medicine, with the potential...