America’s early-stage clinical trials have increasingly moved overseas, raising concerns about the nation’s long-term competitiveness in biomedical innovation.
Biopharmaceutical
The update aims to clarify how manufacturers should approach similarity assessments, indication extrapolation, and post-market safety monitoring.
The partnership will introduce Anthropic’s Claude’s agentic AI capabilities into research, clinical development, manufacturing, commercial operations, and corporate functions.
Makary stepped down amid a widening rift over tobacco regulation and a series of contentious decisions that reshaped the FDA’s internal politics.
The regulator said the goal is to speed up the development of promising therapies by addressing longstanding early-phase delays.
New federal guidance recommends using drugs approved outside of the US as comparators to cut down on pricey pharmacokinetic testing.
The PreCheck program aims to make it significantly less onerous to set up domestic manufacturing plants provided they align with US national priorities.