Day: April 10, 2025

The laboratory testing industry is breathing a collective sigh of relief this week after a federal court struck down the Food and Drug Administration’s (FDA) final rule aimed at increasing regulatory oversight of laboratory-developed tests (LDTs). This ruling marks a significant victory for labs, who argued that the FDA overstepped its authority in attempting to … Read more

A lot has been written about the potential of Real World Data (RWD) and Real World Evidence (RWE) over the last decade. In the latest guidance from a regulatory agency, the European Medicines Agency (EMA) released a reflection paper on using RWD derived from non-interventional studies (NIS) to generate RWE for regulatory purposes. It emphasizes … Read more