Healio8h
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
federalnewsnetwork.com23h
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in Northern California study
Many of modern medicine’s most remarkable achievements have been accomplished through the trust of volunteers, who test new ...
JD Supra1d
FDA Broadens Oversight of Lab-Developed Tests
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...
How a 'secret' recording threatens Delaware's largest drug case in recent years
A recently disclosed recording has appeals attorneys asking a judge to overturn the convictions of Eric "Butter" Lloyd and his codefendants.
JD Supra5d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...