When patient safety, regulatory approval and real-world effectiveness are on the line, AI can't act autonomously.

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 ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

By James Amoh Jnr, GNA Special Correspondent, London, United KingdomLondon (UK), March 30, GNA – Across laboratories ...

Creating a new drug involves significant time, effort, and resources. Many assume drug development is straightforward, with final products approved fairly quickly, but the drug approval timeline can ...

Every clinical trial is built on the promise that the risk is justified by the strength of the evidence supporting it.