Cyberonics answers FDA
This article was originally published in The Gray Sheet
Executive Summary
Neurostim firm submits response Jan. 21 to FDA's December warning letter, asserting that compliance with good manufacturing practice requirements has been established. In a same-day release, CEO Skip Cummins says that "the response also identified the corrective actions already implemented since the beginning of the inspection and the corrective actions Cyberonics will implement in the coming months" (1"The Gray Sheet" Jan. 10, 2005, p. 14). The firm reiterates it expects FDA approval for its VNS Therapy depression indication by the end of January...