Compilation: 2015 Medical Device Warning Letters
This article was originally published in The Gray Sheet
Complete list of all 91 FDA device-related warning letters released by the agency last year. The upshot: 73 domestic and 18 foreign manufacturers were sent letters.
You may also be interested in...
Pink Sheet reporters and editors discuss whether a new report on generic drug prices will affect efforts to green-light government price negotiations, Eli Lilly’s untitled letter for promotion on Instagram, and Oncopeptides deciding to withdraw its accelerated approval withdrawal.
Akili Interactive Labs, which developed the first prescription-only video-game-based platform to be cleared for marketing by the US FDA, recently announced plans to go public through a SPAC merger with Social Capital Suvretta Holdings Corp. I. See what Chamath Palihapitiya, CEO of Social Capital and CEO of Social Capital Holdings Corp. I, said about it here.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.