Day: October 10, 2024

Institutional Review Boards (IRBs) are the surrogates of the FDA for regulating clinical trials by ensuring compliance by the investigators under their purview. But occasionally IRBs may falter in their responsibilities leading to negative audit findings. This is what happened with the IRB at Lousiana State University Health Science Center (LSUHSC) which was found to … Read more

The FDA has been rolling forward with the implementation of the new medical device rules whereby the Lab Developed diagnostic Tests (LDTs) will be converted to conventional In Vitro Diagnostic (IVD) devices or removed from the market. It is the responsibility of the manufacturers of LDTs to navigate the new regulatory environment. A new page … Read more