(Total Views: 287)
Posted On: 06/02/2023 10:46:28 AM
Post# of 600
This is all that matters:
This is all very positive. Correct, the safety and superiority was proven in the human trials.
Unfortunately, the human trials were done with Chinese produced Hemostyp, meanwhile the Hemostyp UHP is proposing to the FDA is USA product that in not meeting the very strict criteria of the FDA who want the new product (once packaged and delivered to hospitals and then unpackaged in the operating room) to be identical to the Human Trials product.
Not “Effectively identical” …but . IDENTICAL. No need for adverbs. Identical is identical.
.” Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval.“
This is all very positive. Correct, the safety and superiority was proven in the human trials.
Unfortunately, the human trials were done with Chinese produced Hemostyp, meanwhile the Hemostyp UHP is proposing to the FDA is USA product that in not meeting the very strict criteria of the FDA who want the new product (once packaged and delivered to hospitals and then unpackaged in the operating room) to be identical to the Human Trials product.
Not “Effectively identical” …but . IDENTICAL. No need for adverbs. Identical is identical.
.” Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval.“
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