The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance (MR) coils under the agency’s safety...

The US Food and Drug Administration (FDA) on Thursday launched a new app called CURE ID that allows health care professionals around the world to report novel uses of existing drugs to treat difficult-to-treat infectious diseases.

The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions wit...

As manufacturers of popular heartburn drugs, like Zantac, continue to pull their products from shelves, the US Food and Drug Administration is now telling the companies to test their drugs for an impurity, known as N-nitrosodimethylamine (NDMA), b...

House Speaker Nancy Pelosi (D-CA) and Democrat colleagues said they will pass a wide-ranging drug pricing bill that many in the pharmaceutical industry have warned would be catastrophic. However, the bill is unlikely to make headway in the Republi...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.