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 ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

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 ...

Chemistry, manufacturing, and controls (CMC) is key in drug development, ensuring novel therapeutics’ consistency, quality, and safety. The approval process for new medications can take 10–15 years, ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Navigating the complex landscape of drug approval presents significant regulatory challenges, requiring a delicate balance between fostering pharmaceutical innovation and ensuring patient safety. The ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...