NEWS! Moving forward with FDA ...... United Hea
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Posted On: 10/31/2022 9:36:05 AM
NEWS! Moving forward with FDA ......
United Health Products Provides Update on FDA PMA Application
9:00 AM ET 10/31/22 | GlobeNewswire
United Health Products Provides Update on FDA PMA Application
Mesquite, NV, Oct. 31, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company's FDA Premarket Approval application and financial reporting calendar.
As previously disclosed in its press release of September 6th, UHP continues to assemble required documentation and test its manufacturing process to complete its FDA application for Class III Premarket Approval of its hemostatic gauze product. UHP, in collaboration with its contract manufacturing partner, have produced rolls of test product and are currently performing physical and chemical evaluations. Concurrently, UHP is completing its audit and assessment of the partner's manufacturing operation to confirm adherence to FDA requirements. The company expects to complete these tasks and work with its FDA consultant to draft and submit a revised application that is fully responsive to the Administration's earlier comments, prior to November 22nd. There can be no assurance that the company's PMA application will be approved.
Separately, UHP expects to file its financial report for the third quarter of 2022 on Form 10-Q no later than November 14th. The report will show that the company generated modest commercial revenue for the first time since 2019, reflecting its reengagement with customers in the U.S. 510k market as well in certain international markets.
United Health Products Provides Update on FDA PMA Application
9:00 AM ET 10/31/22 | GlobeNewswire
United Health Products Provides Update on FDA PMA Application
Mesquite, NV, Oct. 31, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company's FDA Premarket Approval application and financial reporting calendar.
As previously disclosed in its press release of September 6th, UHP continues to assemble required documentation and test its manufacturing process to complete its FDA application for Class III Premarket Approval of its hemostatic gauze product. UHP, in collaboration with its contract manufacturing partner, have produced rolls of test product and are currently performing physical and chemical evaluations. Concurrently, UHP is completing its audit and assessment of the partner's manufacturing operation to confirm adherence to FDA requirements. The company expects to complete these tasks and work with its FDA consultant to draft and submit a revised application that is fully responsive to the Administration's earlier comments, prior to November 22nd. There can be no assurance that the company's PMA application will be approved.
Separately, UHP expects to file its financial report for the third quarter of 2022 on Form 10-Q no later than November 14th. The report will show that the company generated modest commercial revenue for the first time since 2019, reflecting its reengagement with customers in the U.S. 510k market as well in certain international markets.
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