FDA achievements overlooked by critics

It's "tremendously unfair" yet in court it's an effective criticism of the FDA that it is undermanned and sometimes comes up short of fulfilling its mission. But "the amazing thing is how well FDA responds to the challenge" of being asked to do more with less money, writes Jim Beck in The Drug and Device Law blog. The agency faces globalization of food and drug regulation and is seeking harmonization with regulators around the world; it's also scrutinizing importers and moving to risk-based inspections and enforcement. Blog

Suggested Articles

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.

A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.