FDA Reminds 2,200+ Companies Clinical Trial Disclosure Requirements

April 21, 2026

FDA Reminds Sponsors and Researchers to Disclose Clinical Trial Results to ClinicalTrials.gov

Beverly Lorell, MD, Christina Markus, Lauren Roth, D. Kyle Sampson King & Spalding + Follow Contact LinkedIn Facebook X ;) Embed

The Food and Drug Administration (FDA) announced in a news release dated April 13, 2026 that, on March 30, 2026, the agency issued reminders to more than 2,200 medical product companies and researchers of the legal requirement to submit certain results to the public website ClinicalTrials.gov. The registration and submission of results of “applicable clinical trials” is mandated by Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, which amended section 402(j) of the Public Health Service Act) and the Final Rule for Clinical Trials Registration and Results Information Submission (the Rule, codified at 42 C.F.R. Part 11). Under the Rule, FDA oversees compliance and undertakes appropriate enforcement action related to the failure to submit required clinical trial information to ClinicalTrials.gov.

According to the FDA news release, the companies and researchers that received these reminder letters are associated with more than 3,000 registered clinical trials that appear to be subject to the mandatory requirements for submission of trial results, but for which these data have not been submitted and posted on the ClinicalTrials.gov website. FDA determined that these trials lacking submitted results comprised 29.6% of the set of clinical trials the agency analyzed. FDA did not disclose the time period that was examined or the proportion of the studies reviewed that were drug/biological product or device clinical trials.

FDA Commissioner Martin Makary, M.D., M.P.H. stated that failure of disclosure could hide negative trial results leading to “overrepresenting successes and underrepresenting failures.” The news release also warns that FDA has the authority to send Pre-Notices of Noncompliance and Notices of Noncompliance, and it states that the purpose of the March 30, 2026, reminder letters is to seek voluntary compliance before the agency considers further regulatory action.

Regulatory Requirements for Registration and Submission of Results to Clinicaltrials.gov.

The following information must be submitted to ClinicalTrials.gov by the Responsible Party, which is the clinical trial sponsor (unless a principal investigator has been designated as the Responsible Party by the sponsor).

• Applicable clinical trial. In brief, an applicable drug clinical trial is a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a biological product subject to section 351 of the Public Health Service Act, where “clinical investigation” has the meaning given in 21 C.F.R. § 312.3 and “phase 1” has the meaning cited in 21 C.F.R. § 312.21. A clinical trial of a combination product with a drug primary mode of action under 21 C.F.R. Part 3 is also generally considered an applicable drug clinical trial. An Expanded Access clinical study of an investigational drug is not an applicable clinical trial. Note that the term “controlled” means comparison to concurrently or non-concurrently collected human data, including historical controls or a person’s own baseline data. An applicable device clinical trial is a prospective clinical study of health outcomes comparing an intervention with a device product subject to section 510(k), 515, or 520(m) of the FD&C Act against a control in human subjects; a pediatric postmarket surveillance of a device product as required under section 522 of the FD&C Act; or a clinical trial of a combination product with a device primary mode of action under 21 C.F.R. Part 3. It does not include small clinical trials to determine the feasibility of a device product, or clinical trials to test prototype device products where the primary outcome measure relates to feasibility and not to health outcomes.

Applicable clinical trials are “interventional” and meet one or more of the following threshold criteria: (1) at least one study facility is located in the United States or a U.S. territory; (2) the study is being conducted under an Investigational New Drug application or Investigational Device Exemption; or (3) the study involves a drug, biological, or device product that is manufactured in the United States or a U.S. territory and exported for study in another country. The National Institutes of Health, which co-administers the ClinicalTrials.gov program with FDA, provides a checklist to aid sponsors and researchers in determining whether a clinical trial qualifies as an applicable clinical trial for reporting purposes.
- Registration of an applicable clinical trial. Any applicable clinical trial initiated after September 27, 2007 must be registered on ClinicalTrials.gov, and the Responsible Party must submit the registration information specified in the Rule not later than 21 days after the first human subject is enrolled. As specified in 42 C.F.R. § 11.10(a), “enroll” or “enrolled” means a human subject’s, or their legally authorized representative’s, agreement to participate in a clinical trial following completion of the informed consent process. Potential subjects who are screened for the purpose of determining eligibility for a trial, but do not participate in the trial, are not considered enrolled, unless otherwise specified by the protocol.
- Submission of clinical trial results of an applicable clinical trial. Results of applicable clinical trials generally must be submitted no later than 1 year after the primary completion date of the trial, which is defined as “the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.” However, there are exceptions to this requirement. First, a Responsible Party may request an extension for up to two years beyond the one-year submission deadline by certifying that the applicable clinical trial involves an FDA-regulated product that is either unapproved and under development, or approved but for which the sponsor is seeking approval for a new use. The certification must be submitted prior to the original deadline for submitting results information. After submitting the certification, the Responsible Party need not report clinical trial results until 30 days after the product is approved; the application or premarket notification seeking approval is withdrawn without resubmission for 210 calendar days; or, in the case of a new-use application, FDA ends the regulatory review cycle but does not approve the product, whichever occurs first (but no later than two years from the date of the certification submission).

Second, a Responsible Party may request an extension for “good cause.” A good cause extension request must be submitted prior to the deadline on which the clinical trial results information would otherwise be due (i.e., the standard results submission deadline or an extended deadline if an extension request was granted or a certification for delay was submitted). Although the term “good cause” is not defined in statute or regulation, NIH has described situations that may be considered “good cause” as including:

• - the need to preserve the integrity of the science of a study for which data collection is ongoing, including situations in which the submission of results information for the primary outcome(s) of an applicable clinical trial would impair or otherwise bias the ongoing collection, analysis, and/or interpretation of data for secondary outcome(s);
  • emergencies that prevent the timely submission of clinical trial results information, including situations in which one or more data collection sites are affected by natural disasters or catastrophic events outside the Responsible Party’s or sponsor’s control;
  • termination of the study close to the standard results submission deadline; and
  • reporting delays due to unexpected personal emergency circumstances, including emergency situations faced by the Responsible Party or key personnel, such as death or extended personal illness. Third, a Responsible Party may request a waiver from any of the results submission requirements. The waiver request must include a description of extraordinary circumstances justifying the waiver and an explanation of why the waiver is consistent with the protection of public health or in the interest of national security. If the waiver is denied, the responsible party may appeal the denial. Like the extension request, the waiver request must be submitted prior to the original deadline for submitting results.

FDA Enforcement of the Clinicaltrials.Gov Requirements

FDA has the authority to use multiple enforcement tools to address failure of a Responsible Party to comply with the requirements for registration and/or submission of results information. FDA must first determine if the Responsible Party has committed one or more of the following violations:

• Failure to register an applicable clinical trial;
• Failure to submit required clinical trial information, including results, to the ClinicalTrials.gov data bank; or
• Knowingly submitting false or misleading information. Following FDA issuance of a Pre-Notice of Noncompliance requesting voluntary corrective action, the failure of the Responsible Party to address potential violations may trigger additional FDA regulatory actions, including issuance of a formal Notice of Noncompliance. If a Responsible Party fails to take adequate correction action within 30 calendar days after receiving a Notice of Noncompliance, FDA may impose civil money penalties. As of the date of this alert, the FDA website “Pre-Notices for Potential Noncompliance” lists 232 Responsible Parties that have received a Pre-Notice of Noncompliance. The FDA website “ClinicalTrials.gov – Notices of Noncompliance and Civil Money Penalty Actions” lists 8 Responsible Parties that have received a Notice of Noncompliance.

Implications For Sponsors of Clinical Trials.

The FDA news release issued on April 13, 2026, signals that FDA is currently actively identifying sponsors of applicable clinical trials who fail to meet the legal requirements for submission of clinical trial results to ClinicalTrials.gov for public scrutiny, regardless of whether such results are favorable. The news release also signals that this is a priority issue for FDA Commissioner Makary and that he views failure to post trial results as a potential ploy by sponsors to hide unfavorable clinical information. In addition, the issue of “missing data” is now a prominent focus of the New York Times and other media. We encourage sponsors of applicable clinical trials to (1) review current company policies, training, and practices regarding timely and accurate registration and submission of results of applicable clinical trials and (2) promptly correct deficiencies. In addition, sponsors should ensure that other public disclosures regarding the results of clinical trials accurately align with the data that must be submitted to ClinicalTrials.gov.

;) ;) Report

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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