FDA warns Turkeys Gulsah Uretim Kozmetik Sanayi Anonim Sirketi about CGMP violations in its production of finished drugs.
Federal Register notice: FDA revokes 15 Emergency Use Authorizations on 12 decontamination systems for personal protective equipment, one bioburden re...
Two senior CBER vaccine officials announce they are leaving FDA over the next couple of months untimely departures that signal trouble with how the a...
FDA and the Reagan-Udall Foundation hold a two-day meeting on the role of investigational drug labels in medication errors.
FDA releases a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohep...
Former FDA commissioner Scott Gottlieb says the nation needs a coordinated national clinical trial infrastructure for use during public health emergen...
FDA revises its guidance on remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the r...
CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.