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Focus on Regulation

Tag Archives: ClinicalTrials.gov

To certify or not to certify? FDA has answered the question

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.  

Compliance Deadlines for New ClinicalTrials.gov Requirements Explained: What Results to Post and When

As discussed in a previous client alert (here), the Department of Health and Human Services (HHS) recently issued a final rule governing the requirements for public registration of trials and posting of data to the ClinicalTrials.gov database. In a significant expansion over the previous requirements, effective January 18, 2017, responsible parties will have to publicly report the results of more clinical trials, including some for investigational drug products and devices that may never reach the marketplace.