FDA warns Phoenix, AZ-based Abraxis Bioscience about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient in the proposed gene...
FDA raises uncertainties with Verus request for Covid-19 treatment emergency use authorization for its repurposed investigational cancer drug sabizabu...
CDERs Office of New Drugs denies an Omeros appeal of complete response letter on its BLA for narsoplimab as a treatment for hematopoietic stem cell tr...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Angel Medical Systems AngelMed Guardian System....
The Combination Products Coalition says its members have several concerns with recent FDA requests for validation of product interface specifications.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Kyowa Kirins Nourianz (istradefylline).
Two Wiley Rein attorneys caution medical device manufacturers to start preparing their transition plans and marketing applications for devices that we...
