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  • FDA’s New Guidance on “Alternative Tools” for Manufacturing Facility Assessments: What Life Sciences Companies Need to Know

    The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]

  • 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 [...]

  • FDA Issues Draft Guidance on 510(k) Transfer Protocols for Biotech and MedTech Firms

    In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]

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