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Posted On: 07/02/2023 11:56:51 AM
Post# of 581
Way back on July 13th 2022.....Wow a year now?
On July 13 the company and its regulatory consultant met with the full FDA team assigned to review its Class III PMA application. The focus of the meeting was to discuss the procedural approach taken by UHP to address certain observations made by the FDA in its initial review of its PMA application. UHP provided a detailed status assessment for each of the observations and an explanation of actions taken for their resolution.
Brian Thom, UHP’s Chief Executive Officer reported, “while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
Ok so are we now submitting a complete & documented PMA
Did I overlook this significance....."UHP is conducting FDA required testing on its packaged products in collaboration with the company’s U.S. based, FDA certified packaging partner. The test protocol is designed to ensure that products shipped to customers are sterile and are not damaged nor contaminated during transport from the packaging facility."
Watch the pps run back up past a $1 short term!
$5+
On July 13 the company and its regulatory consultant met with the full FDA team assigned to review its Class III PMA application. The focus of the meeting was to discuss the procedural approach taken by UHP to address certain observations made by the FDA in its initial review of its PMA application. UHP provided a detailed status assessment for each of the observations and an explanation of actions taken for their resolution.
Brian Thom, UHP’s Chief Executive Officer reported, “while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
Ok so are we now submitting a complete & documented PMA
Did I overlook this significance....."UHP is conducting FDA required testing on its packaged products in collaboration with the company’s U.S. based, FDA certified packaging partner. The test protocol is designed to ensure that products shipped to customers are sterile and are not damaged nor contaminated during transport from the packaging facility."
Watch the pps run back up past a $1 short term!
$5+
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