Public Access to Results of FDA-Funded Scientific Research
FDA-Funded Research
Public access to the results of FDA-funded scientific research furthers the Agency’s public health mission. The broad availability of scientific information and underlying data allow for the critical review, replication, and verification of findings that are central to the scientific method.
Making research findings and the digital data supporting those findings accessible and analyzable promotes robust and open communication with the scientific community thereby bolstering the credibility of scientific findings and the regulatory decision-making based upon those findings. The availability of FDA scientific information advances public health by spurring scientific discovery, including prompting the scientific community to address critical challenges in medical product development.
Facilitating the free flow of information underlying FDA's decision-making and advances in regulatory science--to the extent permitted by law--enables the public, Congress, media, and industry to better understand FDA’s decisions and the scientific basis for its regulatory decision-making.
Summary of FDA’s Public Access Requirements
Effective August 15, 2025, FDA's public access requirements ensure:
- Immediate availability of scholarly publications and underlying scientific data "as soon as practicable" upon formal publication
- Comprehensive data management planning before research begins, with mandatory approval processes
- Streamlined access through full-text archives and data repositories, including PubMed Central for publications and openFDA for datasets
- Enhanced transparency in research design, methodology, and findings to support scientific reproducibility
For FDA Staff: Research publications and supporting data must be made freely available in full-text archives and public data repositories immediately upon formal publication, supported by approved Data Management Plans developed before research begins.
For FDA-Funded External Research: Funding instruments include requirements for immediate public access to publications and data, ensuring that taxpayer-funded research contributes to the broader scientific knowledge base without delay.
Policy
- Public Access Requirements for Intramural Researchers and FDA Authors of Scholarly Publications Based on FDA-Funded Scientific Research (SMG 2126.5)
- Public Access Requirements for Extramural Research (SMG 2126.6)