FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

Two formative experiences shaped Craig Crews’ path into drug development. First, when he was still a child, his grandmother died from cancer at just 52 years old. “At the time, there weren’t very many ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The troriluzole clinical development program encompassed the first industry clinical trials to generate data showing therapeutic potential in patients with spinocerebellar ataxia (SCA), a rare genetic ...