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ImportantThe U.S. Food and Drug Administration (FDA) issued final guidance on October 20, 2026, outlining how pharmaceutical companies should develop, distribute, and label software applications used alongside prescription…
Trending topicsFDA Advances Implementation of Real-Time Clinical Trials announced two major steps to support the implementation of real-time clinical trials (RTCTs). First, the agency confirmed the initiation of two…
ImportantFDA has requested that drug manufacturers remove suicidal ideation and behavior (SI/B) warnings from the labeling of three GLP-1 receptor agonist (GLP-1 RA) medications used for weight management:…
Trending topicsThe U.S. Food and Drug Administration (FDA) has announced a significant update to its approach to real-world evidence (RWE), removing a major limitation that has long restricted its…
Trending topicsThe U.S. Food and Drug Administration (FDA) has qualified the first artificial intelligence tool for drug development, specifically AIM-NASH, designed to aid pathologists in evaluating metabolic dysfunction-associated steatohepatitis…
Trending topicsThe U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools to all of its employees, marking a significant expansion of the…
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