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Posted On: 08/01/2025 8:06:15 AM
Post# of 594
All is not lost but certainly delayed! Hang in there is my advice!
United Health Products Provides Regulatory Status Update
5:53 PM ET 7/31/25 | Dow Jones
July, 31, 2025 -- (United Health Products, Inc.) -- (NewMediaWire)
MT. LAUREL, NJ - July 31, 2025 (NEWMEDIAWIRE) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussions with the Food & Drug Administration. As previously disclosed, the Company's Investigational Device Exemption (IDE) application was disallowed pending resolution of the FDA Warning Letter issued on March 25, 2015, identifying certain violations of required clinical procedures that occurred during the 2019 clinical trial. On April 14, 2025, the Company submitted a response to the FDA that addresses the violations. As of the current date, the FDA has not responded to the company's submission.
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of its IDE application, UHP has engaged with the FDA's IDE review team (which functions separately from the group that issued the Warning Letter) to seek a path to timely approval of a new IDE and commencement of the clinical study irrespective of the Warning Letter status. UHP has retained a regulatory attorney to support its efforts in this regard and is discussing with the FDA various solutions including, among other options, identifying an alternative sponsor acceptable to the FDA to oversee the new clinical study on the Company's behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate these into a revised PMA application. The Company will make further announcements as FDA discussions progress.
United Health Products Provides Regulatory Status Update
5:53 PM ET 7/31/25 | Dow Jones
July, 31, 2025 -- (United Health Products, Inc.) -- (NewMediaWire)
MT. LAUREL, NJ - July 31, 2025 (NEWMEDIAWIRE) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussions with the Food & Drug Administration. As previously disclosed, the Company's Investigational Device Exemption (IDE) application was disallowed pending resolution of the FDA Warning Letter issued on March 25, 2015, identifying certain violations of required clinical procedures that occurred during the 2019 clinical trial. On April 14, 2025, the Company submitted a response to the FDA that addresses the violations. As of the current date, the FDA has not responded to the company's submission.
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of its IDE application, UHP has engaged with the FDA's IDE review team (which functions separately from the group that issued the Warning Letter) to seek a path to timely approval of a new IDE and commencement of the clinical study irrespective of the Warning Letter status. UHP has retained a regulatory attorney to support its efforts in this regard and is discussing with the FDA various solutions including, among other options, identifying an alternative sponsor acceptable to the FDA to oversee the new clinical study on the Company's behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate these into a revised PMA application. The Company will make further announcements as FDA discussions progress.
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