LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Clinical laboratory sales training expert Peter Francis shares qualities to look for when hiring laboratory sales reps
Andreas Jeromin, PhD, chief scientific officer at ALZPath, discusses the current landscape of blood-based AD tests and their future.
Alison Green, PhD, head of laboratory sciences at Scottish Brain Sciences, discusses recent developments in AD blood tests
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Key cybersecurity points to address when working with a third party that has access to protected health information
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks