Following update was posted on What’s New section of the ClinicalTrials.gov, on July 28, 2020:
Regarding Submission of Results Information for ACTs Subject to the Registration Requirements and Completed Before January 18, 2017, Following the Federal Court Decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020): The Histories, Policies and Laws page and Frequently Asked Questions have been updated to provide clarity to responsible parties:
- Am I required to submit results information for my applicable clinical trial (ACT) if the primary completion date was before January 18, 2017 (the effective date of the Final Rule)? If so, when?
- If the results submission deadline has already passed for an ACT affected by the Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), what is the deadline for submitting results information?
- What are the potential consequences of not submitting required results information for ACTs affected by the Federal Court’s decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020)?