CDER tells Portola Pharmaceuticals that as part of its mid-cycle NDA review for betrixaban, there is no intention to hold an advisory committee meetin...
Physio-Control begins a Class 1 recall of Lifepak15 monitor/defibrillator due to the failure of the device to deliver an electrical shock.
FDA grants Angionetics a Fast Track designation for Generx [Ad5FGF-4], a cardiovascular angiogenic gene therapy for use as a one-time treatment for im...
The Government Accountability Office (GAO) completes a long-awaited report that confirms serious gaps in FDAs medical device reporting process that fa...
Public Citizen asks FDA to immediately remove HES solutions from the market due to increased risks of death and kidney damage.
The National Center for Policy Analysis says that FDA drug approval regulations are a major cause of high drug prices because they eliminate competiti...
Three groups ask a federal court to bar implementation of President Trumps executive order intended to eliminate many federal agency regulations and t...
FDA issues a guidance on when and how to produce Dear Healthcare Provider letters.