Approvals Rely

• Researchers conducted a retrospective review of all novel FDA drug approvals from 2016 through 2024 to analyze the evidence used for authorization. • The study used FDA public records and the ClinicalTrials.gov database to track the number of completed trials and their funding sources. • The findings show that novel drug approvals in the US have been supported by a decreasing number of studies since 2016.

• A retrospective review of FDA novel drug approvals from 2016 through 2024 reveals a trend of approvals being supported by a decreasing number of completed clinical studies. • Researchers analyzed FDA public records and the ClinicalTrials.gov database to evaluate trial counts, funding sources, and the timing of public result reporting. • The findings highlight a concerning shift toward relying on fewer studies and an increase in industry-funded research to secure drug authorizations.

• Researchers analyzed the impact of the 21st Century Cures Act, which allows the FDA to approve novel drugs based on a single pivotal trial rather than multiple studies. • Findings indicate that since 2016, the number of studies supporting new drug approvals in the US has steadily decreased. • This shift reflects a trend toward increased FDA flexibility and a higher reliance on industry-funded data to accelerate the drug approval process.