Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Edwards Lifesciences Sapien XT Transcathet...
FDA approves an Allergan supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include treating hospital-acquired bacte...
Kareway Products recalls 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, four fluid ounces due to the potential for microbial conta...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Lenvima (lenvatinib mesylate) is 3,580 day...
Four House committee leaders ask FDA for a contingency response plan addressing their concerns over the risk of worsening U.S. shortages of heparin du...
A 2/2 letter to FDA from 92 bipartisan members of the U.S. Senate and the House urges the agency to use all tools at its disposal to address the dire ...
CDRH director Jeff Shuren says that consumers should not be alarmed about findings from a new rodent study evaluating cell phone or radiofrequency ene...
Attorney Riette van Laack describes legislation to reform FDAs over-the-counter drug monograph system and allow for user fee funding.