FDA application update..........Progress and conc
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Posted On: 03/29/2023 9:03:52 AM
FDA application update..........Progress and concern but confidence that the company has integrity to verify and confirm the efficacy of the product.
United Health Products Provides Update on FDA PMA Application Process
8:48 AM ET 3/29/23 | GlobeNewswire
United Health Products Provides Update on FDA PMA Application Process
Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval application process.
As disclosed in a press release on January 31, 2023, UHP produced three batch lots of its HemoStyp gauze product to demonstrate consistent manufacturing results, which the company believes to be an important criterion for Premarket Approval. Laboratory testing on samples of these lots was completed to confirm the consistency of the company's manufacturing process, which results are to be included in its final PMA application. The testing results showed several anomalies in product pH level and moisture content that the company, in consultation with the laboratory leadership, believes resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier. The company notes that this process was carried out to create testing samples and is not an element of the standard manufacturing, packaging and sterilization process that will be reviewed by the FDA in the PMA application. UHP notes further that testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples.
In light of these anomalies a second round of testing for manufacturing consistency is underway. The company has produced new batch lots which have been delivered directly to the lab where samples will be taken in a more controlled environment. These samples will then undergo the required tests to confirm the uniformity and consistency of the company's manufacturing process. In parallel with this effort, preparation for packaged product testing by the company's packaging partner will continue, providing necessary confirmation of packaging integrity, effective sterilization and other criteria.
Because the required tests are being performed by external service providers it is difficult to predict with certainty the time to completion of these final steps in the company's PMA application. Based on recent lab performance and detailed discussions with its packaging partner regarding the necessary protocols to establish packaging procedures that meet the rigorous Class III standards, the company now anticipates it may take until the end of June 2023 to complete, analyze and incorporate these procedures and results into a consolidated PMA application.
There can be no assurance that the company's PMA application will be approved.
United Health Products Provides Update on FDA PMA Application Process
8:48 AM ET 3/29/23 | GlobeNewswire
United Health Products Provides Update on FDA PMA Application Process
Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval application process.
As disclosed in a press release on January 31, 2023, UHP produced three batch lots of its HemoStyp gauze product to demonstrate consistent manufacturing results, which the company believes to be an important criterion for Premarket Approval. Laboratory testing on samples of these lots was completed to confirm the consistency of the company's manufacturing process, which results are to be included in its final PMA application. The testing results showed several anomalies in product pH level and moisture content that the company, in consultation with the laboratory leadership, believes resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier. The company notes that this process was carried out to create testing samples and is not an element of the standard manufacturing, packaging and sterilization process that will be reviewed by the FDA in the PMA application. UHP notes further that testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples.
In light of these anomalies a second round of testing for manufacturing consistency is underway. The company has produced new batch lots which have been delivered directly to the lab where samples will be taken in a more controlled environment. These samples will then undergo the required tests to confirm the uniformity and consistency of the company's manufacturing process. In parallel with this effort, preparation for packaged product testing by the company's packaging partner will continue, providing necessary confirmation of packaging integrity, effective sterilization and other criteria.
Because the required tests are being performed by external service providers it is difficult to predict with certainty the time to completion of these final steps in the company's PMA application. Based on recent lab performance and detailed discussions with its packaging partner regarding the necessary protocols to establish packaging procedures that meet the rigorous Class III standards, the company now anticipates it may take until the end of June 2023 to complete, analyze and incorporate these procedures and results into a consolidated PMA application.
There can be no assurance that the company's PMA application will be approved.
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