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USFDA Draft Guidance: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
In May 2026, the FDA Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) issued the draft guidance Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. The guidance introduces risk-based approaches for nonclinical safety assessments of certain oncology biologics and conjugated products, aiming to facilitate development while maintaining patient safety. The guidance highlights that data anal
Sharan Murugan
May 313 min read