Don Segal and Julie Tibbets co-chaired a panel titled "The Aftermath of PDUFA IV for Industry and Investors" on Wednesday, June 18, 10:15am - 11:45am. 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 discussed the impact of this legislation on drug development and marketing practices along with how companies can preserve investor confidence in this new regulatory climate.
Objectives included reviewing the new regulatory initiatives under PDUFA IV and FDA’s implementation and enforcement of these initiatives, discussing how these new provisions are affecting both product development and marketing and exploring the impact of heightened drug safety and scrutiny on investors, and how the industry might minimize investor skepticism.
June 17-20, 2008
San Diego Convention Center / San Diego, CA