FDA clears a MedShape 510(k) for its Eclipse Soft Tissue Anchor, a shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone.
The Alliance for a Stronger FDA urges Congress to provide FDA with an additional $40 million ($2.60 billion total) in budget authority for FY 2014 request.
Takeda Pharmaceuticals supplements a citizen petition submitted earlier this year seeking to block ANDA approval for would-be generic Dexilant (dexlansoprazole) products due to bioequivalence concerns.
Consumers Union urges FDA to adopt a proposed rule requiring metal hip implants and other high-risk implantables to be reviewed through the PMA process.
Federal Register Proposed rule: FDA proposes to revise medical device and biologic product labeling to allow for stand-alone standardized graphical symbols.
Federal Register Notice: FDA sends a proposed collection of information on clinical laboratory improvement amendments waiver applications to the Office of Management and Budget.
Federal Register Notice: The Office of Management and Budget approves a collection of information on the electronic submission of device registration and listing.