College of American Pathologists (CAP) is hosting a 1-hour discussion on this rule on May 23 at 11 AM ET/10 AM CT.
Panelists will discuss:
· Overview of the final rule
· Timeline for implementation
· CAP's recommendations adopted in final rule
· CAP's LDT legislative advocacy efforts going forward
· Q & A
https://www.cap.org/laboratory-improvement/regulatory-updates
------------------------------
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: 04-29-2024 11:03
From: Mark Arnold
Subject: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf
The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.
The impact on clinical trials and in general on patient care remains to be determined.
#fda #LDT #enforcement
------------------------------
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>
------------------------------
</bioanalysisandbiomarkers.blogspot.com></bioanalysisandbiomarkers.blogspot.com>