[ Price : $8.95]
FDA issues a revised guidance on PDUFA user fee waivers, reductions, and refunds.[ Price : $8.95]
Public Citizen says new amendments to the House drug price legislation are an improvement but dont go far enough.[ Price : $8.95]
Lilly says its pancreatic cancer drug misses its primary endpoint in a Phase 3 trial.[ Price : $8.95]
HHSs Office of Inspector General says it is assessing FDAs medical device postmarket surveillance activities.[ Price : $8.95]
ViiV Healthcare submits a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection.[ Price : $8.95]
A CDRH Webinar discusses issues seen in dental device 510(k) submissions and ways in which they can be improved.[ Price : $8.95]
FDA approves a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults a...[ Price : $8.95]
FDA issues a safety alert on Efficient Laboratories Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination ...