Clinical Trial Disclosure Community

Topic: FDA Revises Guidance on 3674 Certifications

1.  FDA Revises Guidance on 3674 Certifications

Posted 10 days ago

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. 

Kind regards,

 

Bob Paarlberg

Chair, CTD Community

 



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