United Health Products Provides Regulatory Update
United Health Products Provides Regulatory Update
Henderson, NV, May 18, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its FDA regulatory process.
亨德森，内华达州，2022年5月18日(环球通讯社)NewMediaWire--联合保健品公司(OTCPK：UEEC)，(UHP)今天提供了其FDA监管程序的最新情况。
Regulatory Review
As previously disclosed, on April 20, 2022, UHP delivered to the U.S. Food & Drug Administration (FDA) a supplemented and e-formatted Premarket Approval (PMA) response for its HemoStyp™ hemostatic gauze and, as is customary, requested a meeting with the committee responsible for reviewing its PMA application. UHP has accepted the FDA's offer to meet on July 6, 2022, and anticipates receiving feedback on its latest response in advance of this meeting. The company will continue to engage with members of the review committee to address any remaining requests and to ensure a productive interaction in July. There can be no assurance that the PMA application will be approved.
监管审查
如之前披露的，2022年4月20日，UHP向美国食品和药物管理局提交了一份补充的电子格式的HemoStyp™止血纱布的上市前批准回应，并按照惯例要求与负责审查其PMA申请的委员会举行会议。UHP已经接受了FDA提出的在2022年7月6日召开会议的提议，并预计在本次会议之前收到对其最新回应的反馈。该公司将继续与审查委员会成员接触，以解决任何剩余的请求，并确保在7月份进行富有成效的互动。不能保证PMA的申请会得到批准。
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
投资者关系：
菲利普·尼梅茨
212 344-6464
邮箱：p.niemetz@panConsultants.com
About United Health Products -- United Health Products develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and consumer markets, and is focused on gaining approval to access the human surgical market.
关于美联航保健品--联合保健品公司开发、制造和营销HemoStyp™，这是一种获得专利的中和氧化再生纤维素止血剂。HemoStyp是一种全天然产品，旨在控制出血。UHP目前向牙科、兽医和消费市场提供一系列止血产品，并专注于获得进入人类外科市场的批准。
For more information on UHP visit: or contact the Company at info@unitedhealthproductsinc.com
欲了解有关UHP的更多信息，请访问：或通过INFO@unitedHealth Productsinc.com联系该公司。
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
根据1995年《私人证券诉讼改革法》所作的安全港声明：本新闻稿可能包含符合1933年《证券法》第27A条(经修订)和《1934年证券交易法》(经修订)第21E条的含义的前瞻性信息，包括含有“相信”、“预期”、“预期”或类似表述的陈述。这些前瞻性陈述涉及已知和未知的风险、不确定因素和其他因素，这些风险、不确定因素和其他因素可能导致公司的实际结果、业绩或成就与这些前瞻性陈述中明示或暗示的大不相同。
译文内容由第三方软件翻译。