Focal gets FDA panel date for May:
This article was originally published in Clinica
Executive Summary
The US FDA's advisory panel will review Focal's premarket approval application for its surgical sealant for stemming air leaks on May 8. The Lexington, Massachusetts-based company's FocalSeal-L was accepted for expedited review in June 1999 (see Clinica No 862, p 20) and has been available in Europe since March 1998. However, results of the FocalSeal-L US clinical trial received some criticism (see Clinica No 848, p 13).