Diversity Now, the first protocol to achieve diversity in clinical trials according to the FDA guidelines for Race and Ethnicity Diversity Plans This plan provides a pharmacist-centered approach for compliance with Section V Categories 4 and 5 of the US Food and Drug Administration’s industry guidance (hereinafter “FDA Guidance”) for developing the required Race and…
The Diversity Issue in Clinical Trials – an overview Pharmaceutical industry discussions on Diversity, Equity, and Inclusion (DEI) all end in the same place—the need to build patient trust. However, there are few suggestions about how to build this trust and little recognition that it will take time. Additionally, trust is only the first step…
U.S. State Laws Govern the Dispensing, Labeling, and Counseling Requirements for Investigational New Drugs When conducting clinical trials, sponsors have traditionally looked to 21 C.F.R. §312, and not state law, for guidance. Upon closer examination of state laws, however, it becomes clear that states throughout the country categorize Investigational New Drugs (“INDs”) as prescription drugs.…