Veyong established the complete quality management system, obtained the ISO9001 certificate, China GMP certificate, Australia APVMA GMP certificate, Ethiopia GMP certificate, Ivermectin CEP certificate, and passed US FDA inspection
But it is unprecedented for a drug to be put on the pathway to widespread adoption in this manner instead of having to go through the more arduous and evidence-based FDA drug approval process, experts say
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Thats why the FDAs own technical staff has recommended against expanded access, and the public health group Partnership for Safe Medicines calls them "popular, unproven, dangerous. As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, puts it: Is the FDA going to stand on science or is it going to permit all kinds of snake oil to be readily available? The FDA meeting will last two days