FDA clears an EmCyte 510(k) for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell ...
Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants.
A Kaiser Health News report posted online by NBC News raises questions about FDA approval of Janssens new depression drug Spravato.
FDA warns Spectrum Laboratory Products about CGMP and other violations in its production of API.
PhRMA says participation in a 4/29 meeting on incorporating patient experience in drug development for rare diseases shows the need for FDA to have a ...
CDER health science policy analyst Lauren Milner explains in a Webinar the reasons for and use of a new draft guidance on submitting documents using r...
FDA grants Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a ritu...
CDERs Office of Compliance sets up a new compounding team with responsibility for the overall management of the agencys drug compounding compliance pr...