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  • AI in cGMP: FDA’s Warning Letter Signals “Human Review Must Be Real”

    FDA just gave the industry a very clear signal about AI in a cGMP environment. In an April 2, 2026 Warning Letter to Purolea Cosmetics Lab, FDA included a section on “Inappropriate Use of Artificial [...]

  • FDA to Phase Out Animal Testing Requirements, Promising Accelerated Cures and Smarter Drug Development

    In April 2025, the U.S. Food and Drug Administration (FDA) unveiled their roadmap designed to reduce, refine, and potentially replace animal testing, beginning with monoclonal antibody therapies and expanding to other drug modalities. This marks [...]

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