FDA approves safety-related labeling changes for Allergans anti-depressant drug Celexa.
The White House Office of Management and Budget completes its review of CDRHs long-awaited proposed rule to modernize the medical device Quality Syste...
FDA approves Allergan Aesthetics Juvderm Volbella XC for an additional indication improving infraorbital (undereye) hollows in adults over the age of...
FDA warns Addison, TX-based Innoveix Pharmaceuticals about producing, packing, and holding sterile compounded drugs in insanitary conditions.
FDA issues an immediately effective guidance intended to discourage the use of so-called sanitation tunnels as a way to prevent or treat Covid-19.
A just-released advisory committee briefing document shows FDA putting its foot down on drug sponsors conducting drug development programs that exclus...
FDA says CDER researchers have developed ways to bridge the gap between in vitro and in vivo assessment of injectable suspensions.
FDA acting chief technology officer Sohail Chaudhry says automation will be a big part of the agencys digital transformation efforts.