Clinical Trial Disclosure Community

Subject: FDA Revises Guidance on 3674 Certifications

1.  FDA Revises Guidance on 3674 Certifications

Posted 06-18-2017 01:33 AM

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  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. 

Kind regards,


Bob Paarlberg

Chair, CTD Community


Robert Paarlberg
Paarlberg & Associates LLC
Canton GA
+1 (404) 345-2804