United Health Products Provides Regulatory Update [Yahoo! Finance]
UNITED HEALTH PRODUTS INC (UEEC)
NASDAQ:AMEX Investor Relations:
unitedhealthgroup.com/investors.aspx
Company Research
Source: Yahoo! Finance
the Food & Drug Administration (FDA) to resolve the Warning Letter issued on March 25, 2025, identifying violations that occurred during the company's 2019 clinical trial. Following recent discussions, the FDA earlier this month formally approved the company's proposal to collaborate with another U.S. manufacturer and distributor of hemostatic products whereby the partner will serve as Sponsor of a new clinical study of UHP's CelluSTAT Hemostatic Gauze, and where the company will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application. This plan will allow a study to proceed (subject to granting of an Investigational Device Exemption) while UHP works with the FDA to resolve the Warning Letter. In addition to its agreement with this clinical study arrangement, the FDA has approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP's protocols, procedures and personnel that was recom
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Sec Filings
- 3/31/26 - Form NT
- 2/2/26 - Form EFFECT
- 1/15/26 - Form S-1
- UEEC's page on the SEC website