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.
Federal Register notice: FDA sends to OMB an information collection revision entitled Prescription Drug User Fee Program.
Federal Register notice: FDA seeks comments on an information collection extension entitled Establishment Registration and Device Listing for Manufact...
An Oklahoma pension fund initiates a securities fraud class action suit against Biogen and its top executives over the controversial Aduhelm approval.
The Biotechnology Innovation Organization recommends changes to an FDA draft guidance on data standards for real-world data in drug and biological pro...