Regulacje i polityka gospodarcza · 22.11.2022

Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials

On October 26, 2022, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled "Request for Information (RFI) on Clinical Research Infrastructure and Emergency Clinical Trials." This RFI invited comments on improving the U.S. clinical trials infrastructure and in particular, our ability to carry out emergency clinical trials. In accordance with the 2022 National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (National Biodefense Strategy) and the American Pandemic Preparedness Plan (AP3), OSTP, in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP has determined that an extension of the comment period until January 27, 2023 is appropriate.