Medical Devices
FDA Clears Abbott FreeStyle Libre Glucose Sensor
FDA clears Abbotts next-generation FreeStyle Libre 3 14-day continuous glucose monitor.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 5/27/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 5/27/2022.
Medical Devices
ArjoHuntleigh Polska Recalls Floor Lifts
ArjoHuntleigh Polska recalls its Sara Plus floor lift following several complaints of smoke or flames coming out of the device.
Federal Register
Guide on Prostate Cancer Drug Development
Federal Register notice: FDA makes available a final guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues....
Human Drugs
FDA Extends Shelf Life for Lillys Bentelovimab
FDA extends the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is cur...
Medical Devices
FDA Approves Medtronic In.Pact 018 Balloon Catheter
FDA approves Medtronics In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatme...
Federal Register
HHS Withdraws SUNSET Final Rule
Federal Register notice: Health and Human Services withdraws a final rule entitled Securing Updated and Necessary Statutory Evaluations Timely (SUNSET...
FDA General
Senate Unveils User Fee Reauthorization Bill With FDA Enhancements
The Senate Health, Education, Labor and Pensions Committee introduces a bill to reauthorize FDAs user fee programs in addition to provisions to streng...
