Prashant Kumar 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 With the release of the ICH M4Q(R2) draft guidance, the long-standing framework established in 2002 is finally getting a high-tech makeover designed to align it with current status of the digital technology.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 With its new draft guidance, FDA explains how Bayesian methods, that were previous described for medical devices, can be used for drugs and biologics as well, but with guardrails.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
As digital health technologies continue to proliferate, regulatory boundary setting has become increasingly critical. FDA’s 2026 update to its General Wellness policy refines the Agency’s enforcement posture for low-risk products. For regulatory professionals, this guidance provides essential insight into FDA’s current interpretation of device scope and risk. On January 6, 2026, the U.S. Food and … Read more
The FDA has released updated recommendations on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. These clarifications are intended to support consistent, compliant communication practices across the sector. Stakeholders involved in regulatory affairs, medical affairs, and commercial operations will find the document particularly relevant. The U.S. Food and Drug Administration’s guidance, Promotional Labeling … Read more
A major shift is unfolding in the world of CAR-T-cell therapy, and it didn’t come through a formal FDA guidance or regulation. Instead, it arrived as a “perspective” article in a top medical journal, authored by the FDA’s CBER leadership. Beneath its calm academic tone lies a seismic message: the era of open-label CAR T … Read more
The FDA has issued an updated version of its eCopy Program guidance, providing clarifications to an established electronic submission framework in place for more than a decade. The revisions primarily refine expectations, align terminology, and integrate the program more closely with eSTAR and current electronic submission pathways. For medical device sponsors, the document functions as … Read more
