Regulatory Oversight and Viral Safety in the US Plasma Sector Safety is the paramount concern in the US blood plasma derivatives industry, governed by the strict oversight of the Food and Drug Administration (FDA). The US has pioneered many of the "Multiple-Gate" safety protocols used today, including nucleic acid testing (NAT) and advanced viral inactivation steps such as solvent-detergent treatment and nanofiltration. These rigorous standards ensure...
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