FDA calls on isotretinoin manufacturers to propose a workable solution to issues with the iPLEDGE REMS Web site and telephone call center so treatment...
FDA warns Kirkland, WA-based Amcyte Pharma it is illegally selling Nasitrol, an unapproved and misbranded drug, as a Covid-19 cure.
FDA grants AbbVie a breakthrough therapy designation for telisotuzumab vedotin and its use in treating certain patients with advanced/metastatic epide...
Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information To Understand Challenges and Opportunitie...
FDA says the Cybersecurity and Infrastructure Security Agency has identified vulnerabilities in the Fresenius Kabi Agilia Connect Infusion System.
FDA amends the Pfizer/BioNTech vaccine EUA to allow booster shots for those ages 12 to 15 and a shorter period between primary and booster shots.
CDRH officials say they are working toward normal review times in FY 2022.
FDA classifies as Class 1 a recall by Medtronics Covidien unit of its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly err...