FDA GUIDANCE · FINALMarch 18, 2026

Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Investigation & Enforcement, Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality

Issue date

March 18, 2026

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