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introduces notable modifications to the FDA approval process, emphasizing the importance of diversity in clinical research.
Introduces notable modifications to the FDA approval process, emphasizing the importance of diversity in clinical research.
FDORA addresses the long-standing issue of underrepresentation in clinical trials. Historically, the FDA encouraged but could not enforce the inclusion of diverse patient populations in late-stage clinical trials.
This led to a lack of comprehensive data on how different demographic groups responded to FDA-regulated products.
Under FDORA, sponsors conducting phase 3 clinical trials or other pivotal studies for drugs and devices are now required to submit “diversity action plans.” These plans aim to ensure the inclusion of a broad spectrum of participants, covering various racial, ethnic, gender, and social backgrounds.
The objective is to obtain more representative data, which can lead to better and more inclusive healthcare outcomes.
By requiring diversity action plans, FDORA aims to improve the generalizability of clinical trial results. This ensures that the safety and efficacy of new drugs and devices are assessed across a wide range of populations, ultimately leading to more equitable healthcare solutions.