FDA officials suggest approaches to improving medical device early feasibility studies in the U.S.
Cantrell Drug Co. recalls certain unexpired sterile drug products due to lack of sterility assurance.
FDA Review posts Federal Register notices for the week ending 11/18/2016.
Federal Register Notice: FDA seeks comments on an information collection extension on medical device premarket notifications.
Federal Register Notice: FDA seeks comments on an information collection extension on its Guidance for Industry on Special Protocol Assessment that de...
Federal Register Final Rule: FDA amends its current good manufacturing practice and labeling regulations regarding medical gases to require that porta...
FDA says it is delaying guidelines for regulating laboratory-developed tests until after the Trump administration takes office in January.
CDRH, The National Health Information Sharing and Analysis Center, and the Medical Device Innovation, Safety and Security Consortium sign an agreement...