FDA: Diversity Action Plan guidelines

Last update: October 7th, 2024

  1. Press release, by the FDA

  2. FDA Guidance document (DRAFT): “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry”

Guidelines relevant for differential aspects between human population:

  • Center for Drug Evaluation, Research. S10 Photosafety Evaluation of Pharmaceuticals [Internet]. U.S. Food and Drug Administration. FDA; 2020 [cited 2024 Jun 26].

  • In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions. VIEW

Image taken from FDA document: “In Vitro Drug Interaction Studies Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” LINK

Note: in this FDA guideline, no reference about the differences between ancestries is made - please look at the PharmGKB database to understand allele frequency differences and high risk alleles that are more prevalent in specific populations.

More information in the section “High risk variants”