FDA warning letter: Boston Scientific's post-Guidant euphoria short-lived
This article was originally published in Clinica
Just two days after wresting Guidant over from Johnson & Johnson, Boston Scientific could find the deal it fought so hard to win in jeopardy after the company received a warning letter from the FDA concerning its overall corporate quality management system.
You may also be interested in...
The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
Stada has appointed a head of digital communications; PGEU elects new chair and vice-chair; and the new UK health claims committee unveils its first members.