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 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2020-P-1405

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

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensMay 20, 2020

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CBER to bioMérieux	Mar 18, 2026	--

Comment Statistics

Total Comments

Keywords

CDER

bioMerieux

recognize recombinant Factor C (rFC)

method equivalent toexistingcompendial methods

bacterial endotoxin testing

Limulus amoebocyte lysate (LAL)

CLOSED

Data from Regulations.gov