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  4. Demographic Data Summaries for CBER Novel Biological Approvals by Year
  1. Guidance, Compliance & Regulatory Information (Biologics)

Demographic Data Summaries for CBER Novel Biological Approvals by Year

Diverse group of people

 

Section 3601 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) established requirements to enhance diversity in clinical trials for certain clinical studies for drugs, biological products, and devices to increase enrollment of participants who are members of historically underrepresented populations in clinical studies, to help improve the strength and generalizability of the evidence for the intended use population. CBER publicly posts new biological approvals with supporting documents, which include demographic data for the clinical trials used to support licensing.

Below are tables of the demographic data summaries for CBER novel biological approvals for each calendar year (January 1st -December 31st).

January 1, 2022—December 31, 2022, Demographic Data Summary

 

 

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