June 13, 2022. We strongly support FDA’s proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. For too long, clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. However, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations.
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NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
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