The U.S. Food and Drug Administration "is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health."
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.
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.
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.
For peer-reviewed manuscripts, the FDA uses PubMed Central (PMC).
The FDA expects researchers to use discipline-specific data repositories, wherever available.