Published in Medical Letter on the CDC and FDA, April 17th, 2005
The company plans to continue the ongoing clinical benefit trial and expects to continue discussions with the FDA about ways to enhance the trial, including, as previously announced, the addition of a higher dose to the study.
This decision follows a number of meetings with the FDA since October 2004, when the company received an approvable letter...
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA