by Soller R W, Chan P V, Shaheen C
Soller R W. et al. OTC Considerations for Rx-to-OTC Switch. SelfCare 2011;2(5):117-138
Consumer behavior studies and thorough reviews of Rx drug safety and efficacy are expected components of Rx-to-OTC new drug applications in the U.S. Understanding the expectations of the Food and Drug Administration (FDA) for these studies and other data required for switch is vital for successful OTC drug development programs.