FDA grants MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastoma.
FDA Webview editor Jim Dickinson urges commissioner Robert Califf to begin rulemaking to establish a regulatory definition of substantial equivalence ...
FDA says it will accept until 12/11 applications for its new Digital Health Technologies Advisory Committee.
Federal Register notice: FDA seeks comments on an information collection entitled Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and ...
A Tufts Center for Biomedical System Design analysis says cell and gene therapies are more likely to be successful than other therapies in specified s...
Two Reed Smith attorneys explain how FDA may grant a breakthrough device designation to medical devices that have the potential to address and improve...
Sen. Richard Blumenthal (D-CT), in a second complaint, urges FDA to join the U.S. Department of Justice to thoroughly investigate whether Philips Resp...
Hyman, Phelps & McNamara hires former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulatory expert.
