International regulatory collaboration has passed an important early test, providing the faintest glimmer of hope that the FDA might actually be able to achieve some of the conflicting goals ...

Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request seeking a label update for Winrevair, a treatment already approved in ...

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. FDA has also reached ...