"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Pharmaceutical ...

The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Please provide your email address to receive an email when new articles are posted on . AIM-MASH AI Assist is the first AI drug development tool to be qualified by the FDA. The tool is designed to ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. BOSTON — Replimune Group and ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...