FDA clears an Intuitive 510(k) for the da Vinci SP robotic surgical system for use in certain transoral otolaryngology procedures in adults.
An opinion piece by former FDA associate commissioner Wayne Pines predicts that most initiatives undertaken by commissioner Scott Gottlieb will contin...
Cook Medical recalls one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that crea...
Hospira recalls three lots of sodium bicarbonate injection USP, 50 mEq/50 mL (1 mEq/mL) due to the presence of particulate matter, which has been conf...
New budget document shows that FDAs medical product programs could benefit most from the Trump Administrations proposed 7% boost ($419 million) to the...
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices: Use of Symbols in Labeling Glossary to Suppor...
FDA Review posts the Federal Register notices for the week ending 3/15/2019.
Federal Register notice: FDA makes available a final guidance entitled Enrichment Strategies for Clinical Trials to Support Demonstration of Effective...