FDA OTC Switch Risk Mitigation Strategy for US Sponsors in 2023 – Insight 7 FDA OTC Switch Risk Mitigation Strategy for US Sponsors in 2023 – Insight 7 The transition of a prescription (Rx) drug to an over-the-counter (OTC) status has significant implications for stakeholders, from regulatory professionals to market access strategists. This comprehensive guide outlines the step-by-step process of implementing a risk mitigation strategy when planning an Rx to OTC switch in compliance with FDA regulations. Emphasizing actionable strategies, we will navigate this complex regulatory landscape while ensuring adherence to ICH-GCP standards. Step 1: Understanding the Rx to OTC…