United Health Products, Inc. (OTCPK: UEEC), (UHP) today confirmed it has submitted its response to the Food & Drug Administration's (FDA) most recent questions and comments on the company's Pre-market Approval (PMA) application. At this time there are no outstanding FDA information requests to UHP, however, the FDA reserves the rights under its review process to request additional information at any time.
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market is HemoStyp products for human surgical procedures. There can be no assurance that a PMA will be granted by the FDA.
About United Health Products -- United Health Products develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and consumer markets, and is focused on gaining approval to access the human surgical market.
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Original Source: United Health Products Provides Regulatory Update