OTC Drug Development

OTC CONSIDERATIONS FOR EXPANDING ACCESS TO NONPRESCRIPTION MEDICINES: A CRITICAL SYNTHESIS OF QUESTIONS FROM THE FOOD AND DRUG ADMINISTRATION TO ITS ADVISORY COMMITTEES ON RX-TO-OTC SWITCH

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.

WARNINGS IN OTC PRINT ADVERTISEMENTS – POSTER

by Mulvaney M, Soller RW, Rice L, Negerete MJ
Mulvaney M, Soller RW, Rice L, Negerete MJ. Warnings in OTC print advertisements – Poster. SelfCare 2012;3(6):138. Poster1

The aim of this section is to encourage the publication of student/junior faculty research projects, offering an opportunity for young and more seasoned junior researchers to publish their research in this form. Poster submissions are subject to an independent review process.