Request the FDA to recognize recombinant Factor C (rFC) as a method equivalent to existingcompendial methods of bacterial endotoxin testing [Limulus amoebocyte lysate (LAL) and Tachypleus tridentatus lysate (TAL)] and to amend the biologics regulations using Executive Orders 13771 and 13777
🏛 Food and Drug Administration (FDA)FDA-2020-P-1405
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