FDA publishes a draft guidance on the drug development platform technology designation program.
Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file required annual repor...
Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...
Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...
Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy.
An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screening in adults age 45 ...
Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units du...
