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 US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its ...

A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." ...

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...

DENVER — A "huge" number of life-years is being unnecessarily lost because of delays in cancer drug approvals, according to research presented here at the 16th World Conference on Lung Cancer. Every ...

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

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.

A common understanding of how to develop a facilitating ecosystem would create a rising tide that would raise all boats in the pursuit of effective treatment and cures for rare diseases. Robert Califf ...

How do they come up with the brand names for prescription drugs? The brand name drug Lyrica sounds nothing like the actual ...