FDA gives PMA approval to Seno Medical Instruments Imagio diagnostic breast cancer imaging technology.
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications as Used by the Food...
Three University of Pennsylvania medical school health policy experts propose a way to keep necessary political involvement in FDA decisions from inte...
Outgoing FDA commissioner Stephen Hahn says he was under significant White House pressure on Covid vaccines and treatments.
FDA issues an immediately effective guidance on methanol testing in drug products during the Covid-19 public health emergency.
FDA Review posts the Federal Register notices for the week ending 1/15/2021.
Federal Register notice: FDA reschedules a public meeting for 2/12 on Patient- Focused Drug Development for Vitiligo.
Federal Register notice: FDA announces a 4/7 virtual public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data S...