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- FDA Issued Updated Patient-Focused Drug Development Guidance on . . .
Key Takeaways: 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 (COAs),” 1 in October 2025 The document provides a structured approach to integrating patient perspectives into clinical trial endpoints, ensuring that outcome measures are
- FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates . . .
Today, the U S Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated
- FDA issues plan to reduce primate testing for certain antibodies
FDA issues draft guidance to reduce primate testing for certain antibodies By Darren Incorvaia Dec 2, 2025 11:25am animal testing animal models Food and Drug Administration (FDA) monoclonal antibodies
- FDA takes steps to limit non-human primate testing
The FDA has published new guidance aimed at reducing or stopping toxicity studies of monoclonal antibody-based drugs in non-human primates (NHPs), in the latest stage of an ongoing effort to
- New Draft Guidance Highlights FDA Push Toward Human-Relevant Safety . . .
Key Takeaways The FDA's draft guidance suggests eliminating some non-human primate toxicity studies for monoclonal antibodies, reflecting a shift towards modernizing nonclinical assessments Alternative methodologies, including organoid systems and computational models, are gaining traction for generating human-relevant safety insights earlier in drug development The guidance aligns with a
- FDA issues draft guidance to reduce six-month nonhuman primate . . . - dvm360
On December 2, 2025, The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates (NHPs) can be reduced or eliminated According to the FDA, this move is part of a
- FDA指导原则合集（FDA Guidance Documents）-持续更新-药研库
本文持续更新FDA的指导原则并打包，方便离线检索查阅,内容覆盖从FDA发布的从1975至今的所有指导原则，截至2025年7月22日，FDA共发布2275个指南文件。
- FDA–AACR Strategies for Optimizing Dosages for Oncology Drug Products . . .
In 2023, the FDA issued a draft guidance titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases” to encourage a more deliberative approach to dose selection and optimization for oncology drugs
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