Applied Clinical Trials-08-01-2002

Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.

Many stakeholders have already commented on the EU?s incentives for pediatric drug development.

Paul Bleicher shares his regulatory philosophy and perspective and defends his position regarding eSource, in response to June?s Guest Commentary.

PDUFA III boosts manufacturer fees to expand postapproval surveillance and support new FDA review initiatives.

Everybody wants faster cycles and and quicker turnarounds with NDAs. In the U.S., will it soon be possible to go from testing to approval in 1000 days?

Studies show that electronic diaries get better results than paper diaries. These authors explain why.