BioProcess International

Regulatory Frameworks for Central Nervous System Safety Assessment: Bridging Traditional Methods and New Modalities

Despite new methodologies and flexible regulatory pathways, CNS biopharmaceuticals still face significant safety assessment ...

One weird thing that’s been holding drug trials back

For more than 60 years, this blank slate approach has been the Food and Drug Administration’s gold standard — and for good ...
ascopubs.org

Impact of Food and Drug Administration Project Optimus Guidance on Design of Early-Phase Clinical Trials

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...
Pharmabiz

US FDA issues guidance on modernizing statistical methods for clinical trials

US FDA issues guidance on modernizing statistical methods for clinical trials: Maryland Wednesday, January 14, 2026, 09:00 Hrs [IST] The US Food and Drug Administration today publ ...