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FDA Draft Guidance Calls For Trial Diversity Plans

 
• By Alaric DeArment

Many companies have been signaling their commitment to diversity and inclusion in trials, but the new draft guidance spells out how they should address it and what the FDA wants to see.

FDA released a draft guidance on trial diversity and what the agency expects from sponsors • Source: Alamy

A growing number of drug makers have publicly made commitments to increase trial diversity, especially in response to the COVID-19 pandemic, but a new draft guidance from the US Food and Drug Administration formalizes and spells out how they should plan to address the issue and what kinds of information the agency wants to see.

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