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Focus on Regulation

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.  

The requirement for such a certification is contained in the Public Health Service Act, as amended by FDAAA in 2007.  The statute is intended to provide a mechanism for the public to learn about certain clinical trials that are being conducted, as well as summary results information of those trials.  Under the statute, certain types of FDA applications must include a certification stating that the sponsor has met all applicable requirements of the clinicaltrials.gov requirements, namely the requirement to register applicable clinical trials. However, the statutory language does not explain what types of “application or submission” should be accompanied by a certification of compliance.

While it was well understood that certifications would be required for clinical trials included in certain product applications (e.g., NDA, BLA, PMA), FDA has now made it clear that they will also require certifications for INDs and other applications.   In order to address any uncertainty about when such certifications are needed, the recent guidance lists the following types of applications and submissions (including resubmissions) where a certification should be included:

  • IND
  • New Clinical Protocol submitted to an IND
  • NDA
  • Efficacy Supplement to an approved NDA
  • BLA
  • Efficacy Supplement to an approved BLA
  • ANDA
  • PMA
  • PMA Panel Track Supplement
  • HDE
  • 510(k) that refers to, relates to, or includes information on a clinical trial

However, the guidance also states that FDA intends to exercise enforcement discretion with regard to submission of certifications with the following four categories of applications and submissions:

  • Supplements to an approved NDA, BLA, or PMA other than an efficacy supplement (for NDAs and BLAs) or a panel track supplement (for PMAs)
  • Supplements to an approved ANDA
  • INDs for expanded access under 21 USC 360bbb
  • Submission of 510(k)s which do not refer to, relate to, or include information on or from a clinical trial

FDA’s reasoning here is that in contrast to the types of applications and submissions requiring certification, the majority of supplements to approved NDAs, BLAs, and PMAs do not refer to, relate to, or include information on or from a clinical trial.  Because FDA believes that the statutory purposes would not be furthered by the submission of certifications with these four categories, the agency intends to exercise enforcement discretion regarding certification with these applications and submissions.

If you have any questions about the new guidance or the clinicaltrials.gov requirements more generally, please contact one of the authors of this post or the Hogan Lovells attorney with whom you regularly work.