Dear Clinical Trial Disclosure Community,
On 7 June 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. The law firm of Hogan Lovells has also provided a summary of the revised guidance.
Thanks to Francine Lane for bringing this to the Community's attention.
Chair, CTD Community