FAQ on United Health Products' Regulatory Status Update
Summary
United Health Products, Inc. provides an update on its efforts to resolve FDA regulatory issues and advance its hemostatic gauze product towards approval, highlighting ongoing discussions with the FDA and potential strategies for moving forward.
What is the main topic of the update from United Health Products?
The update focuses on the company’s current status regarding its discussions with the FDA about resolving a Warning Letter and advancing its Investigational Device Exemption (IDE) application for its hemostatic gauze product.
Why is the FDA Warning Letter significant for United Health Products?
The FDA Warning Letter, issued due to violations during a 2019 clinical trial, has led to the disallowance of the company’s IDE application, delaying its ability to conduct further clinical studies and seek approval for its product.
How is United Health Products addressing the FDA Warning Letter?
The company submitted a response to the FDA on April 14, 2025, addressing the violations and is engaging with the FDA’s IDE review team to explore solutions, including identifying an alternative sponsor for a new clinical study.
Who is involved in the discussions with the FDA?
United Health Products has retained a regulatory attorney to support its efforts and is in discussions with the FDA’s IDE review team, separate from the group that issued the Warning Letter.
When did United Health Products submit its response to the FDA?
The company submitted its response to the FDA on April 14, 2025, but as of the current date, the FDA has not responded.
What is CelluSTAT Hemostatic Gauze?
CelluSTAT Hemostatic Gauze is an all-natural product developed by United Health Products, designed to control mild to moderate bleeding, for which the company is seeking approval to access the human surgical market.
What are the implications of the current regulatory status for United Health Products?
The unresolved FDA Warning Letter and IDE application status create uncertainty for the company’s timeline to commence clinical studies and seek product approval, potentially delaying market access.
How can I get more information about United Health Products?
For more information, visit the company’s website at www.uhpcorp.com, contact them via email at [email protected], or reach out by phone or text message at 475.755.1005.
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