Binodh, yes we should form a small team to move this forward. If anyone from the BA community is interested in joining this team, please reach out. There are a couple of interested BPM community members that have volunteered already.
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Karen Quadrini, PhD
Director, Clinical Biomarkers
Prothena Biosciences
Brisbane, CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 06-05-2025 13:47
From: Binodh DeSilva
Subject: FDA doesn't appeal decision to vacate LDT Final Rule
Karen, Mark we should try to see if we can pull a program together. We may not have sufficient information but at least we can start the conversation and then move to a full program for next year.
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Binodh DeSilva Ph.D.
Senior Vice President
Ultragenyx
Skillman NJ
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-04-2025 20:31
From: Mark Arnold
Subject: FDA doesn't appeal decision to vacate LDT Final Rule
Binodh,
I'm not on this year's SPC or RFC to know if the topic has already been submitted, but the only option left is for a Rapid Fire and the deadline is 16June. Perhaps the BioA and Biomark & Precision Medicine Communities will work together on something.
Regards,
Mark
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
Original Message:
Sent: 06-04-2025 19:24
From: Binodh DeSilva
Subject: FDA doesn't appeal decision to vacate LDT Final Rule
Mark
Are we able to put a programming in place to discuss this topic at AAPS.
Binodh
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Binodh DeSilva Ph.D.
Senior Vice President
Ultragenyx
Skillman NJ
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-03-2025 13:22
From: Mark Arnold
Subject: FDA doesn't appeal decision to vacate LDT Final Rule
On Friday or Saturday - depending on who your read - the FDA did not file an appeal to challenge to the Texas District Court decision to vacate the LDT Final Rule. That means the Final Rule is dead as written. Lots of articles out there on the topic - here are just three:
https://www.ascp.org/news/news-details/2025/06/02/the-ldt-final-rule-is-officially-dead--fda-has-no-jurisdiction
https://www.medtechdive.com/news/FDA-declines-appeal-lab-developed-tests-LDTs-ruling/749667/
https://news.bloomberglaw.com/health-law-and-business/fda-skips-move-to-revive-suit-over-agencys-lab-test-authority
#fda #LDT #FinalRuleVacated
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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</bioanalysisandbiomarkers.blogspot.com></bioanalysisandbiomarkers.blogspot.com>