Medical Devices
FDA Clears Zimmer JuggerStitch Meniscal Repair
FDA clears a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 9/13/2019.
FDA General
Since Our Last Issue ...
Industry mews you may have missed since our last issue.
Federal Register
Guide on Special 510(k) Program
Federal Register notice: FDA makes available a final guidance entitled The Special 510(k) Program.
Human Drugs
Carcinogen NDMA Now Spreads to Heartburn Drugs
An FDA safety alert says that an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has now spread to some ra...
Human Drugs
FDA Biosimilar Bioanalytical Best Practices Coming
FDA says it will develop bioanalytical best practices for biosimilar biological product development.
Human Drugs
Warning on CDK 4/6 Inhibitors Lung Condition
FDA warns that Pfizers Ibrance (palbociclib), Novartis Kisqali (ribociclib), and Eli Lillys Verzenio (abemaciclib) used to treat some patients with ad...
Human Drugs
KRS Global Recalls Drugs Over Sterility
KRS Global Biotechnology recalls all lots of unexpired human and animal drugs due to sterility concerns.
Medical Devices
Sterigenics Sterilization Facility Temporarily Closed
FDA says Sterigenics contract sterilization facility in Atlanta, GA is temporarily closed while it undergoes construction to reduce ethylene oxide emi...
Medical Devices
Qfix Encompass 15-Channel Head Coil Cleared
FDA clears a Qfix 510(k) for the Encompass 15-Channel Head Coil, a diagnostic imaging device for use with the Encompass MR SRS Immobilization Device.
