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Increased Diversity in Clinical Trials for Drugs and Medical Devices

This act aims to boost participation of diverse demographic groups (age, sex, race, ethnicity) in clinical trials for drugs and medical devices. Companies will need to submit diversity plans and report on their progress, ensuring that medical products are safe and effective for everyone. Citizens can expect medical products to be better tailored to the needs of a diverse population.
Key points
Drug and device companies must plan and report on how they include diverse age, sex, race, and ethnic groups in their clinical trials.
If companies fail to meet diversity targets, the FDA can require additional studies after product approval to gather missing data.
The act mandates public meetings and reports on progress in increasing trial diversity and using real-world evidence.
Financial support for community health centers to participate in clinical trials and reach underrepresented communities.
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Additional Information
Print number: 117_HR_6584
Sponsor: Rep. Eshoo, Anna G. [D-CA-18]
Process start date: 2022-02-03