Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.

The Guidance and Policy Team (GPT) within the Office of Clinical Pharmacology (OCP) at the US Food and Drug Administration (FDA) was established in 2016 to ensure development and issuance of timely, relevant guidances and policies in the multidisciplinary field of clinical pharmacology. Here, we share our operational model for guidance development, describe our philosophy on collaboration, and detail the impact on clinical pharmacology guidances and policies with a goal of increasing transparency among stakeholders.