On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become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…
Expertise: Clinical Development 61 results
Clinical Development
The Power of Clinical Data: Why Strategic PMCF Studies Matter
Clinical Development
The Power of Clinical Data: Why Strategic PMCF Studies Matter
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…
Clinical Development
Target Product Profile Checklist: Laying the Foundation for Early-Stage Assets
A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success.
Clinical Development
Accelerating Innovation Together
Clinical Development