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
The Food and Drug Administration (FDA) is racing to make coronavirus tests more widely available. Our Food, Drug & Device/FDA Team examines how the FDA is using its authority to issue emergency use authorizations (EUAs) to...more
Our Food, Drug & Device/FDA Team discusses why the Food & Drug Administration is engaging with personal protective equipment (PPE) manufacturers and how it’s providing information to health care providers to mitigate...more