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 With the release of the ICH M4Q(R2) draft guidance, the long-standing framework established in 2002 is finally getting a high-tech makeover designed to align it with current status of the digital technology.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 With its new draft guidance, FDA explains how Bayesian methods, that were previous described for medical devices, can be used for drugs and biologics as well, but with guardrails.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
Animal testing has long been considered a necessary step in drug development; however, the FDA is now revising that narrative. A new draft guidance aims to modernize outdated toxicology practices and significantly reduce the use of animals in the development of monoclonal antibodies. This shift not only reflects scientific progress but also a broader commitment … Read more
FDAMap, a global regulatory and clinical expert firm, is significantly expanding its focus on regenerative medicine in South America. The company is actively collaborating with local healthcare providers and patients to advance access to and the development of safe, non-manipulated stem cell therapies in the region. FDAMap’s core initiative centers on non-manipulated stem cells, primarily … Read more
