Expertise: Clinical Development 61 results

Clinical Development

FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions…

Clinical Development

5 Essentials for Building a Robust Target Product Profile

A Target Product Profile (TPP) serves as the primary strategic framework that aligns commercial and clinical workstreams. When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it starts by keeping the end in mind. Defining the needs of patients, physicians, and payers…