Berndt, Gottschalk, and Strobeck focus on the interactions between the Food and Drug Administration (FDA) and the biopharmaceutical companies that perform drug R and D.

• Position: Conferences

Berndt, Gottschalk, and Strobeck focus on the interactions between the Food and Drug Administration (FDA) and the biopharmaceutical companies that perform drug R and D. To assess the current issues and the state of communication and interaction between the FDA and industry, the authors carried out a survey of industry leadership in R and D and regulatory positions, as well as senior leadership at the FDA with responsibility for drug evaluation and oversight. Based on 49 industry and 8 FDA interviews, the authors find that industry seeks additional...