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USFDA Draft Guidance: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
In May 2026, the FDA Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) issued the draft guidance Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products.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
UK MHRA Project Orbis: Accelerating Global Access to Innovative Cancer Medicines Through International Regulatory Collaboration
The global regulatory landscape for oncology medicines is increasingly moving toward collaborative review models that enable faster patient access to innovative treatments. One of the most significant initiatives in this area is Project Orbis, a multinational programme that allows concurrent submission and review of promising cancer medicines across several international regulatory authorities. The UK Medicines and Healthcare products Regulatory Agency (MHRA) guidance on Proj
Sharan Murugan
May 313 min read