Tuesday, April 11
Having a hard time getting through to FDA? Find that inspectors and field review people are singing completely different tunes? Or is working with the Agency pure pleasure? Please take this survey, as soon as possible, to let the Agency, your peers and all concerned parties know.
This morning, a group of experts including Eliot Parks, Managing Director of Life Sciences for Biocom, Karen Midthun of FDA, and laywer John Manthei, discussed the 11-year-old survey, why it exists, and what it may achieve. The Agency's working hard to improve its processes, yet a "real disconnect" continues to exist between the Agency and industry. Eliminating that disconnect is critical, if drug development and manufacturing are to improve----so take a few minutes. They may pay off hugely.