Update on United Health Products' FDA PMA Application
MT. LAUREL, NJ – United Health Products, Inc. (OTCPK: UEEC) has provided important updates regarding its FDA Premarket Approval (PMA) application. The company submitted this application on March 21 and subsequently received a "Deficiencies Letter" from the FDA on June 18. This letter contained various questions and comments related to different aspects of the application.
In response, United Health Products submitted a Submission Issue Request to the FDA on August 15. This request specifically addressed the questions raised and outlined the company’s strategies for addressing the identified deficiencies. Additionally, the company has requested a video conference with the FDA PMA review team to discuss its responses and proposed solutions for any outstanding issues. This meeting is expected to take place in early September.
Brian Thom, Chief Executive of United Health Products, remarked, “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 lasts 180 days, with approximately 90 days already elapsed. It is important to note that this review period will be paused while United Health Products continues discussions and works to address any remaining deficiencies.
It is crucial to understand that there is no guarantee that the PMA application will receive FDA approval.
About United Health Products
United Health Products focuses on the development, manufacturing, and marketing of HemoStyp™, a patented hemostatic agent made from Neutralized Regenerated Cellulose. This innovative product is entirely natural and specifically designed to control bleeding. The company provides a wide range of hemostatic products aimed at the dental, veterinary, and emergency medicine sectors and is actively pursuing approval to enter the human surgical market.
Contact Information
For more information about 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 FDA review, with a 'Deficiencies Letter' received and a response submitted to address the raised issues.
2. When does United Health Products anticipate the FDA meeting?
The meeting with the FDA PMA review team is expected to occur in early September.
3. What is HemoStyp™?
HemoStyp™ is a patented hemostatic agent designed to control bleeding, primarily marketed in the dental, veterinary, and emergency medicine sectors.
4. How can I contact United Health Products?
You can reach 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 guarantee that the PMA application will be approved by the FDA.
