United Health Products Update on FDA Approval Process
United Health Products Provides Update on FDA PMA Application
MT. LAUREL, NJ – United Health Products, Inc. (OTCPK: UEEC) has recently shared significant updates regarding its FDA Premarket Approval (PMA) application process. The company submitted its PMA application on March 21 and received a "Deficiencies Letter" from the FDA on June 18. This letter outlined various questions and comments concerning multiple aspects of the application.
In response, on August 15, United Health Products submitted a Submission Issue Request to the FDA. This request addressed specific questions and outlined the company’s strategies to tackle the highlighted deficiencies. The company has also requested a video conference with the FDA PMA review team to further discuss its responses and the proposed measures to resolve any outstanding concerns. Expectations are set for this meeting to occur in early September.
Brian Thom, Chief Executive of United Health Products, stated: “We look forward to an interactive engagement with the FDA to gain clarity on what actions and information are needed in order to make a final determination on the merits of our PMA application.”
The FDA's review period for the application spans 180 days, with roughly 90 days already having passed. Importantly, this review period will be paused while United Health Products engages in further discussions and works to rectify any remaining deficiencies.
It is important to note that there is no guarantee that the PMA application will ultimately receive FDA approval.
About United Health Products
United Health Products specializes in the development, manufacturing, and marketing of HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent. This innovative product is entirely natural and is designed specifically to control bleeding. The company offers an extensive range of hemostatic products targeting the dental, veterinary, and emergency medicine sectors and is actively seeking approval to enter the human surgical market.
Contact Information
For further details regarding United Health Products, please visit the company’s official website or reach out via email. The current contact methods are:
Website: www.uhpcorp.com
Email: info@uhpcorp.com
Phone/Text: 475.755.1005
Frequently Asked Questions
1. What is the status of United Health Products' PMA application?
The PMA application is currently under review by the FDA, with a 'Deficiencies Letter' received and a response submitted to address the issues raised.
2. When does United Health Products anticipate the FDA meeting?
The meeting with the FDA PMA review team is expected to take place in early September.
3. What is HemoStyp™?
HemoStyp™ is a patented hemostatic agent designed to control bleeding and is marketed primarily in the dental, veterinary, and emergency medicine fields.
4. How can I contact United Health Products?
You can contact United Health Products via their official email at info@uhpcorp.com or by phone/text at 475.755.1005.
5. Is FDA approval guaranteed for United Health Products' application?
No, there is no assurance that the PMA application will be approved by the FDA.
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