We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Good Manufacturing Practice (GMP) is a system or protocol for ensuring product safety and consistency according to quality standards. GMP is important in all manufacturing industries, though it is ...

The US Food and Drug Administration (FDA) has hit Philips with a warning letter after quality control shortcomings were uncovered at three of its medical device manufacturing sites. Issued on 9 ...

A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s Cellares has passed another major production milestone. Cellares’ automated ...

Late this week, the FDA dished up a pair of manufacturing write-ups, with one going to high-flying Samsung Biologics and the other to India’s Nectar Lifesciences. In Samsung’s case, the regulatory ...