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Very Bad Manufacturing Practices

Nobody knows what's in the vials.
49

Use of EUA covered countermeasures under Public Health Emergency cannot constitute a clinical investigation (21 USC 360bbb-3(k)).

Therefore, these countermeasures could not be tested for safety and efficacy in accordance with US law (CFR 21), nor could compliance with current Good Manufacturing Practices (cGMP) or Good Distribution Practices (cGxP in gen…

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Authors
Sasha Latypova