FDA steps up enforcement on trial disclosure and compliance violations
The FDA reminded more than 2,200 sponsors and researchers to submit required clinical trial results and said 29.6% of likely reportable studies lacked posted results. It also issued warning letters over CGMP violations at a contract manufacturer and protocol failures that led to excessive dosing in a clinical study.
The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov, and it has also issued warning letters to a contract drug maker for failing to meet current good manufacturing practices and to a clinical investigator for failing to ensure site staff complied with the clinical investigation plan. According to an internal analysis, 29.6% of studies that are highly likely to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov.
Certain clinical trial sponsors and researchers are required to submit clinical trial results information to ClinicalTrials.gov one year after trial completion. On March 30, 2026, the agency sent messages to more than 2,200 companies and researchers associated with more than 3,000 registered clinical trials, including some that were publicly funded, that do not appear to have submitted required results information to ClinicalTrials.gov, or that may have not completed the National Library of Medicine's quality control review process. The messages seek voluntary compliance with requirements, and the agency said it also may send Pre-Notices of Noncompliance and Notices of Noncompliance as part of risk-based compliance efforts related to ClinicalTrials.gov.
Studies subject to the mandatory reporting requirements include interventional studies with a U.S. nexus and an FDA-regulated product that are past the deadline to report; it excludes Phase 1 and device feasibility studies. The messages issued on March 30, 2026, represent an extra step the agency is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action.
The agency also issued a warning letter to Australian drug contract manufacturer Cosmetic Manufacturers Pty for failing to meet CGMP requirements. Among the violations recorded by inspectors, the company was cited for failing to ensure its final products met specifications, including not ensuring that it evaluated its products for all critical quality attributes, not testing them for the identity and strength of the active ingredient or for foreign matter, and not evaluating the preservative content.
The agency said the company did not commit to reevaluating its batch release criteria to ensure they are appropriate and cited it for failing to have laboratory controls to ensure the final product meets specifications. Inspectors also noted that the company lacked written production and process control procedures to ensure that final products meet specifications and said it did not use the right production equipment in the right places to allow it to be cleaned and maintained. While the company stated that it has ceased drug production, the agency asked it to notify regulators if it plans to restart manufacturing any regulated products.
A separate warning letter went to an internal medicine doctor in New Hampshire and a researcher at Activmed Practices and Research for failing to follow the investigational plan of a study that he was leading. The agency said he failed to ensure his staff followed a study protocol on multiple occasions and failed to adhere to protocol requirements for four out of four enrolled subjects over multiple study visits. The investigational plan required the randomization of subjects to receive one of three weekly doses — 1.5 mg, 4.5 mg, or 9.0 mg — of the investigational drug or the matching placebo, and subjects in the 4.5 mg and 9.0 mg treatment arms were subdivided into two different titration arms with different titration regimens beginning at 1.5 mg and increasing to the target randomized dose.
The agency listed instances when study subjects received excessive doses of the investigational drug. It said the corrective and preventive actions described in the written response were inadequate because they did not include sufficient details regarding the training or procedures implemented at the site to prevent similar violations in the future and did not provide sufficient details about how the clinical investigator would ensure adequate oversight of study procedures, including adherence to protocol-specified dosing requirements.