FDA "real-time" reviews for PMA supplements expanded to all ODE divisions.
This article was originally published in The Gray Sheet
Executive Summary
FDA "REAL-TIME" PMA SUPPLEMENT REVIEW EXPANDED TO ALL ODE DIVISIONS, agency staffers say. After testing the program in the Division of General and Restorative Devices, the agency is encouraging sponsors of premarket approval application supplements to contact ODE to determine if its supplement can be reviewed under the pilot.