Curated News
By: NewsRamp Editorial Staff
July 31, 2025
UHP Awaits FDA Response on Clinical Trial Violations and IDE Approval
TLDR
- United Health Products, Inc. is navigating FDA challenges to secure approval for its CelluSTAT Hemostatic Gauze, aiming to gain a competitive edge in the human surgical market.
- UHP has submitted a response to FDA violations from a 2019 trial and is exploring options like an alternative sponsor to proceed with a new clinical study.
- Approval of UHP's CelluSTAT Hemostatic Gauze could revolutionize surgical bleeding control, offering a safer, all-natural solution to improve patient outcomes worldwide.
- Discover how UHP's innovative CelluSTAT Hemostatic Gauze, made from Neutralized Regenerated Cellulose, could change the game in surgical bleeding management.
Impact - Why it Matters
The resolution of UHP's FDA Warning Letter and the approval of its IDE are critical steps toward bringing CelluSTAT Hemostatic Gauze to the human surgical market. This development is significant for healthcare providers and patients seeking innovative, natural solutions for bleeding control, potentially improving surgical outcomes and patient care.
Summary
United Health Products, Inc. (OTCQB: UEEC) has provided an update on its ongoing discussions with the Food & Drug Administration (FDA) regarding the resolution of a Warning Letter issued in 2015, which identified violations during a 2019 clinical trial. The company submitted a response to the FDA on April 14, 2025, addressing these violations, but has yet to receive a response. Despite the uncertainty surrounding the resolution of the Warning Letter, UHP is actively engaging with the FDA's IDE review team to expedite the approval of a new Investigational Device Exemption (IDE) and commence a clinical study. The company has enlisted a regulatory attorney to navigate these discussions and is exploring options such as identifying an alternative sponsor to oversee the new study, while retaining full rights to the data for a revised Premarket Approval (PMA) application. UHP's flagship product, CelluSTAT Hemostatic Gauze, is an all-natural hemostatic agent designed to control bleeding, with the company aiming to enter the human surgical market. For more details, visit www.uhpcorp.com.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, UHP Awaits FDA Response on Clinical Trial Violations and IDE Approval
