Exhibit 096 ยท Agency register
ClinicalTrials.gov notices of noncompliance
If a responsible party does not take adequate corrective action within 30 calendar days after receiving a Notice of Noncompliance, FDA has authority to pursue regulatory or enforcement actions, which could include civil money penalties, injunctions, and/ or criminal prosecution.
FDA's table of ClinicalTrials.gov notices of noncompliance lists 12 notices, the oldest being Acceleron Pharma (NCT01727336), notice dated 27 April 2021, response dated 13 December 2021, and the latest Duchesnay on 19 October 2026. The table records no penalty outcomes.
- Source
- U.S. Food and Drug Administration
- Date
- April 2021 onward
- Quoted from
- FDA Notices of Noncompliance page (content current as of 10/30/2026), paragraph 3
- Grade
- Primary record
- Document
- https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/clinicaltrialsgov-notices-noncompliance
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- First-notice announcement: https://content.govdelivery.com/accounts/USFDA/bulletins/2d64939 (28 April 2021).