FDA drug delivery workshop
This article was originally published in The Gray Sheet
Executive Summary
Event is slated for later this summer, "with the idea that we know that when there's a guidance written...you've got almost twice the chance of getting the first cycle of approval...than you do with no guidance written," CDRH Director David Feigal remarks at AdvaMed annual meeting March 22 in Aventura, Fla. The workshop is part of a agency-wide initiative to improve problematic regulatory paths (1"The Gray Sheet" March 24, 2003, p. 11)...