FDA refuses to be ghosted on clinical trial data

The FDA Amendments Act of 2007 and its implementing regulations at 42 CFR Part 11 require sponsors and other responsible parties for certain clinical trials of FDA-regulated products to submit trial results information to ClinicalTrials.gov. On March 30, 2026, FDA sent the messages to companies and researchers following an internal FDA analysis that determined nearly 30% of studies identified as likely to be subject to mandatory reporting requirements have not submitted any results information to ClinicalTrials.gov.

These mandatory reporting requirements generally apply to interventional studies of FDA-regulated products (drugs, biologics, and devices) that meet one of the following conditions:

• The trial has one or more sites in the United States.
• The trial is conducted under an FDA investigational new drug application or investigational device exemption.
• The trial involves a drug, biological, or device product that is manufactured in the US or its territories and is exported for research.

Phase 1 clinical trials and medical device feasibility studies are exempt from the mandatory reporting requirements. The clinical trial results information that must be reported includes primary and secondary outcome measures, adverse events, and certain administrative data. Typically, results must be submitted within a year after the primary completion date of a clinical trial.

In the press release, FDA claims that the missing clinical trial results information presents a serious gap in the public record and that such gap may create a distorted perception of the safety and efficacy of medical products. FDA described the March 30 messages as seeking “voluntary compliance” and characterized them as “an extra step” to give sponsors and responsible parties the opportunity to comply before the agency considers further regulatory action. However, the agency made it clear that additional enforcement tools remain available. FDA stated that it may issue pre-notices of noncompliance and formal notices of noncompliance as part of risk-based compliance efforts.

The messages to clinical trial sponsors and researchers clearly signal FDA’s heightened enforcement posture with respect to clinical trial reporting obligations. Under the FDA Amendments Act of 2007, responsible parties that fail to submit required trial results information may be subject to a public notice of noncompliance on ClinicalTrials.gov, civil monetary penalties of up to $10,000 for all violations adjudicated in a single proceeding, and the withholding of federal grant funding. If the responsible parties fail to submit the required clinical trial results within 30 days of the notice of noncompliance, the responsible parties could face additional penalties of $10,000 per day for each additional day the violation goes uncorrected. Responsible parties may also face injunctions and criminal prosecution. In the past, FDA has largely relied on pre-notices of noncompliance to prompt responses by clinical trial sponsors or other responsible parties. Since 2013, FDA has issued 232 pre-notices of noncompliance. FDA has only escalated to issuing a notice of noncompliance eight times but has not yet assessed civil monetary penalties for noncompliance.

The heightened enforcement posture could increase the risks to sponsors submitting marketing applications that require sponsors to certify compliance with ClinicalTrials.gov registration and reporting obligations. Mandatory disclosure of missing clinical trial results, especially negative clinical trial results, may increase volatility in the life sciences marketplace, particularly for smaller companies with narrow pipelines. The enforcement escalation also creates new securities fraud exposure where sponsors made positive pipeline statements while withholding unfavorable results. In the mergers and acquisitions context, small biotechnology companies often rely on positive clinical trial data to attract acquisition interests. With more complete reporting of clinical trial results, the signaling value of positive clinical trial data may increase as the background rate of visible clinical trial failures rises. Greater visibility into the full clinical trial history of targets, including prior failure that may not have been previously disclosed, could result in more conservative bids for targets.

Next steps

In light of the increased enforcement risks for noncompliance, clinical trial sponsors and responsible parties should conduct a review of completed and ongoing clinical trials to determine whether all reporting obligations have been satisfied. As part of this process, sponsors and responsible parties should confirm that the designated responsible party for each clinical trial is accurate and up to date in the ClinicalTrials.gov system, especially where organizational changes, mergers, or investigator transitions may have created ambiguity. Entities responsible for conducting and reporting the results of clinical trials should also assess whether internal policies and governance frameworks adequately address the timely reporting of clinical trial results and update such policies and compliance trainings as necessary.

The McDermott difference

McDermott Will & Schulte will continue to monitor the FDA’s enforcement of clinical trial results reporting obligations. If you have questions about how these developments may affect your business, please contact the authors or a member of our Food, Drug & Medical Device Group.