Rx-to-OTC Switch: Developing a Compelling Science-Based Submission for the FDA

Categories: Rx-to-OTC Switch

An Rx-to-OTC switch submission depends on well-designed consumer studies that show consumers can follow the Drug Facts label and use a drug safely and effectively in the nonprescription setting.

Our experts can help you:

  • Draft and evaluate OTC Drug Facts Labels, Consumer Information Leaflets, and behavioral support materials
  • Plan and help design the overall development program, including label comprehension studies, self-selection studies, actual use trials and tailored consumer studies

Drs. Janine Pillitteri and Christine Sweeney are two of our behavioral scientists who can help make your Rx-to-OTC switch submission a reality.