The rapid emergence and re-emergence of viral pathogens—exemplified by outbreaks of influenza, Ebola, Zika, and, most recently, SARS-CoV-2—underscore the ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

AI in Cancer Drug Discovery could prove paradigm shifting, but what challenges does it present? And how can they be avoided?

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...