FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have been fired, according...
FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.
FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.
A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and OTC drugs and to ma...
A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of separate sampling l...
FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contains undeclared active...
FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufactured with CGMP viola...
FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patients with acute-on-ch...
