"Few drugs these days make it through the Food and Drug Administration with a "first pass" approval. With the public and agency growing increasingly risk-averse, the drug safety and other provisions enacted under the recent Prescription Drug User Fee Act (PDUFA IV) present new regulatory hurdles for the industry. Government officials and industry members will discuss the impact of this legislation on drug development and marketing practices along with how companies can preserve investor confidence in this new regulatory climate."

Objective1:Review the new regulatory initiatives under PDUFA IV and FDA 's implementation and enforcement of these initiatives.

Objective2:Discuss how these new provisions are affecting both product development and marketing.

Objective3:"Explore the impact of heightened drug safety and scrutiny on investors and how industry might minimize investor skepticism."