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CDER health science policy analyst Lauren Milner explains in a Webinar the reasons for and use of a new draft guidance on submitting documents using r...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...
Provention Bio says that a recent study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of cl...
Federal Register notice: FDA reopens the comment period on a 2/17 Federal Register notice entitled Quality Considerations for Continuous Manufacturing...
Federal Register notice: FDA announces an 11/18 The public workshop entitled Development of Best Practices in Physiologically Based Pharmacokinetic (P...