In Brief: FDA's "real-time"
This article was originally published in The Gray Sheet
Executive Summary
FDA's "real-time": Agency completes first review under program in early May with approval of a premarket approval application supplement for labeling changes to DePuy's LCS Total Knee System. The PMA supplement had been pending for about two months when DePuy asked to participate in the pilot. FDA and DePuy staff members held a teleconference to discuss the application on April 30. FDA requested additional data, which the firm provided within the five days stipulated by the agency; FDA responded with an approval letter. DePuy says the interaction "worked very well," noting that it plans to participate with future supplements...