FDA says it has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products.
Federal Register notice: FDA releases a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions...
Federal Register notice: FDA makes available a draft guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
Federal Register notice: FDA makes available a draft guide entitled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Developme...
Oscor Inc. recalls its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns.
Ventana Medical Systems recalls (Class 1) multiple detection kits due to a potential for false negative results caused by reagent dispenser issues.
FDA says it is preparing a significant update to its guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices....
FDA launches a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improve the efficiency of ...