5 Questions
What do FDA guidance documents, including the Pyrogen and Endotoxins Testing guidance, establish?
Recommendations and current thinking
When did FDA first indicate that an LAL test could be used as a finished product test for endotoxins?
1983
What does the use of the word 'should' in Agency guidances indicate?
It is suggested or recommended, but not required
What was the purpose of the last guidance document mentioned in the text, 'Guideline on Validation of the Limulus Amebocyte Lysate Test'?
To validate the LAL test as an end-product endotoxin test
What did FDA's 1983 guidance suggest about the use of LAL test for endotoxins?
It could be used as a finished product test
Test your knowledge on pyrogen and endotoxins testing with this quiz based on the FDA's guidance document. Covering questions and answers related to industry guidelines, this quiz will help you understand the Agency’s current thinking on the topic.
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