The FDA's Staff Manual Guides 2126.4 (SMG 2126.4)- Access to Results of FDA-Funded Scientific Research provides details regarding the FDA's implementation of processes to ensure public access to scientific publications and digital data that arise form FDA funding.
Digital data is defined in the FDA guide "as the digitally recorded factual material that would be commonly accepted in the scientific community as necessary to validate published, peer-reviewed scientific articles."
Extramural FDA-funded researchers must comply with the policy related to peer-reviewed articles if the articles result from a grant, contract or assistance agreement related to scientific research that is initiated or renewed, on or after December 29, 2015.
Extramural FDA-funded researchers must comply with the policy related to data management if their contract, grant or assistance agreement related to scientific research is initiated or renewed, on or after October 1, 2016.
The data management policy does not apply to research that only acquires, collects or otherwise uses data excluded from the definition of digital data.
The FDA uses the National Institutes of Health Manuscript Submission System (NIHMS) to allow researchers to submit the final, peer-reviewed version of their articles.
For additional information on using NIHMS, please see the following:
Either the final published article or the final peer-reviewed manuscript is required to be deposited in PubMed Central.
The final peer-reviewed manuscript is the version of the article that has been accepted for publication and includes all changes made by the author during the peer-review process. It does not include the publisher's formatting.
The time before an article will be freely available to the public is typically called the embargo period.
For the FDA, the maximum allowed embargo period is 12 months from date of publication.