[ Price : $8.95]
Collegium Pharmaceutical submits a supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-det...[ Price : $8.95]
Vascular Solutions begins a Class 1 recall of its Twin-Pass Dual Access catheters because there is a potential for excess manufact...[ Price : $8.95]
Two CDRH presenters discuss provisions of a final guidance on patient preference information and how the Center uses such informat...[ Price : $8.95]
Pfizer asks FDA to reconsider its decision not to grant five-year exclusivity to Duavee, which contains both a new active moiety a...[ Price : $8.95]
Federal Register Notice: FDA announces the availability of additional draft and revised draft product-specific bioequivalence reco...[ Price : $8.95]
Federal Register Notice: FDA announces an 11/3 Pharmacy Compounding Advisory Committee meeting at the agencys White Oak campus (Si...[ Price : $8.95]
Federal Register Notice: FDA begins accepting additional nominations for members to serve on CDRHs Patient Engagement Advisory Com...[ Price : $8.95]
FDA clears an Etiometry 510(k) for its Risk Analytics Algorithm that is intended to inform physicians and nurses in the intensive ...