Recent FDA videoconference...."The purpose of the
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Posted On: 11/11/2024 9:23:37 AM
Recent FDA videoconference...."The purpose of the meeting was to present, discuss and seek feedback from the FDA on the company’s proposed resolutions to the deficiencies. Topics discussed include the company’s clinical testing (including the results of its human trial), biocompatibility, product sterilization and shelf life. This meeting has provided the company with certainty on how to address the deficiencies, with many of the issues already having been resolved."
Shelf life and product sterilization were previously addressed by FDA and replied to but apparently FDA did not review their own documentation IMO.
Get your act together FDA! CelluSTAT (fka HemoStyp) efficacy is proven.
$5-$10+
Shelf life and product sterilization were previously addressed by FDA and replied to but apparently FDA did not review their own documentation IMO.
Get your act together FDA! CelluSTAT (fka HemoStyp) efficacy is proven.
$5-$10+
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