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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA Releases 2024 Drug Trials Snapshots Summary Report
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has released the 2024 Drug Trials Snapshots Summary Report. The report summarizes CDER’s 2024 Drug Trials Snapshots (DTS) program, illustrating the demographic groups represented in the clinical trials for the 50 novel drugs approved in 2024. The report provides a summary of the demographic groups by sex, race, ethnicity, age group, and U.S. participation for each of the approved novel drugs. Overall, about 31,000 patients participated in these trials. The report highlights male and female participants, age of participants, and the extent of U.S. participation.
CDER created the DTS transparency initiative in 2015 to report on the representation of participants in clinical trials and to the extent possible, to summarize the safety and effectiveness data by sex, age, race, and ethnicity. For more information about the DTS program, please contact Snapshots@fda.hhs.gov.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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