Day: October 22, 2026

Digital health technologies are rapidly transforming prescription therapies from traditional chemical compounds into integrated software-and-drug health systems. As mobile applications and connected devices increasingly accompany pharmaceuticals, life science companies face a complex regulatory matrix. To clarify these boundaries, the FDA issued a new guidance outlining how drug labeling authorities apply to Prescription Drug Use-Related Software … Read more

Embedded pragmatic clinical trials (ePCTs) test interventions in routine healthcare settings using existing infrastructure, such as electronic health records (EHRs) and frontline clinicians. Unlike traditional trials with strict eligibility criteria and controlled conditions, ePCTs enroll broader, more representative populations to assess whether interventions work in everyday clinical practice. The FDA supports this approach through initiatives … Read more