Day: May 21, 2026

The successful commercialization of orally administered therapeutic entities hinges on a meticulous understanding of systemic exposure variability. When developing novel small molecules or modified-release formulations, clinical pharmacologists must strictly characterize the impact of physiological states on drug absorption. The intersection of gastrointestinal physiology and xenobiotic metabolism presents a complex regulatory hurdle for sponsors seeking marketing authorization. Failing … Read more

The FDA’s Digital Health Center of Excellence recently operationalized the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program to address the dichotomy between stringent premarket review timelines and iterative software life cycles. Launched in tandem with the Center for Medicare and Medicaid Innovation’s (CMMI) ACCESS model, TEMPO establishes an unprecedented mechanism for early-stage real-world deployment. Understanding the mechanics of this pilot … Read more