Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more
Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical...more
As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more