Prashant Kumar What if regulatory decisions reflected not just clinical endpoints, but what patients truly value? What if benefit–risk assessments explicitly accounted for patients’ willingness to accept uncertainty, risk, or trade-offs? The FDA’s adoption of ICH E22 signals its perspective on using patient preferences for regulatory decisions by formalizing how structured patient preference data can be designed, … Read more
For decades, pharmaceutical manufacturing steadily migrated overseas, leaving the U.S. dependent on fragile global supply chains. With the launch of the FDA PreCheck pilot program, the agency is offering manufacturers something long requested: regulatory predictability before product submission. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by facilitating the construction of U.S.-based … Read more
What’s the real impact of the FDA’s post-market safety authorities on drug safety actions? A new analysis published in JAMA Internal Medicine explores how post-approval safety measures, including withdrawals, boxed warnings, and safety communications, have evolved since the FDA Amendments Act (FDAAA) of 2007. The findings challenge assumptions about how quickly safety issues are identified … Read more
The 2025 CDRH Annual Report provides a comprehensive overview of the Center’s continued progress in balancing the review of new medical technologies with the rigorous oversight of patient safety. This latest update shows the FDA meeting its commitment to predictable regulatory pathways, ensuring that both manufacturers and patients can rely on consistent standards of excellence. … Read more
In the fast-paced world of oncology, every second counts for patients awaiting life-saving treatments. The FDA’s Assessment Aid is a game-changing tool designed to strip away administrative red tape and put the focus back on what matters most: critical scientific evaluation. By streamlining the communications between drug developers and regulators, this initiative is redefining the … Read more
The era of human-exclusive regulatory review has officially come to an end. With the formal update to SOPP 8217, the FDA is no longer just “experimenting” with machine learning; they are operationalizing it within the core of the IND review process. By introducing a dedicated AI reviewer from the Office of Biostatistics and Pharmacovigilance (OBPV), … Read more
ICH recently updated how the manufacturing section of the CTD is documented. With the release of the ICH M4Q(R2) draft guidance, the long-standing framework established in 2002 is finally getting a high-tech makeover designed to align it with current status of the digital technology. The latest update is a strategic shift toward structured data and … Read more
What if your clinical trial could formally learn from the past, without sacrificing regulatory rigor? What if probability itself became part of the evidence FDA evaluates? With its new draft guidance, FDA explains how Bayesian methods, that were previous described for medical devices, can be used for drugs and biologics as well, but with guardrails. … Read more
Artificial intelligence is increasingly embedded within FDA-regulated drug development activities, from nonclinical modeling to clinical trial execution and post-market surveillance.As AI systems begin to influence regulatory decision-making, FDA expectations for validation, control, and documentation are converging with established GxP software requirements.This week the FDA and EMA jointly released the Guiding Principles of Good AI Practice … Read more
Clinical decision support software now sits squarely at the intersection of digital innovation and device regulation. With its January 6, 2026 update, FDA has materially refined the boundary conditions for when CDS functions are excluded from device status under the FD&C Act. For sponsors, developers, and regulatory strategists, the guidance signals a tightening of expectations … Read more
