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# AstraZeneca Seeks More Input on Study Diversity
- URL: https://www.fdaweb.com/astrazeneca-seeks-more-input-on-study-diversity/
- Published: 2023-10-09T12:00:00.000Z
- Updated: 2026-09-14T19:01:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155519

AstraZeneca is asking FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to collect data/information on diverse representative populations. In just-released comments on the agency’s draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials,” the [company says](https://downloads.regulations.gov/FDA-2022-D-2629-0005/attachment%5F1.docx?ref=fdaweb.com) it seeks clarity on FDA preferences or recommendations regarding the inclusion of data on underrepresented populations obtained from non-clinical trial sources. “For example,” it asks, “would the FDA allow race, ethnicity, sex, age, geographic location, gender identity, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity and safety data from early access in the U.S. before market approval, externally sponsored research (ESR), or from studies conducted with collaborative groups?”

Additionally, AstraZeneca suggested that FDA offer more recommendations on leveraging open-label extension studies, where feasible, to collect additional data on underrepresented populations.