Improved dialog in early switch discussions would benefit industry, NDMA's Soller says.
This article was originally published in The Tan Sheet
Executive Summary
FDA, OTC COMPANIES "DATA-DRIVEN" EARLY SWITCH DISCUSSIONS on OTC candidates may help deter the agency's initial dismissal of potential non-prescription drug substances or categories, Nonprescription Drug Manufacturers Association Senior VP and Director of Science & Technology William Soller, PhD, suggested during a session on Rx-to-OTC switches at the Ohio Pharmaceutical Seminar in Columbus April 21. Discussing current challenges in the area of switches, Soller noted that discouraging exchanges between drug applicants and FDA can hold back the process.