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For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved...
On April 13, 2022, the U.S. Food and Drug Administration ("FDA") issued a draft guidance providing specific recommendations to the industry on how to improve diversity in clinical trials.
On April 13, 2022, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance providing specific recommendations to the industry on how to improve diversity in clinical...
On April 13, the Food and Drug Administration (FDA) published a new draft guidance that, for the first time, recommends that sponsors of clinical trials for submission to ...
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s...