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Questions and Answers
What do FDA guidance documents, including the Pyrogen and Endotoxins Testing guidance, establish?
What do FDA guidance documents, including the Pyrogen and Endotoxins Testing guidance, establish?
- Legally enforceable responsibilities
- Recommendations and current thinking (correct)
- Best practices for industry compliance
- Specific regulatory or statutory requirements
When did FDA first indicate that an LAL test could be used as a finished product test for endotoxins?
When did FDA first indicate that an LAL test could be used as a finished product test for endotoxins?
- 1975
- 1983 (correct)
- 1990
- 2000
What does the use of the word 'should' in Agency guidances indicate?
What does the use of the word 'should' in Agency guidances indicate?
- It is an industry standard
- It is a legal obligation
- It is suggested or recommended, but not required (correct)
- It is a mandatory requirement
What was the purpose of the last guidance document mentioned in the text, 'Guideline on Validation of the Limulus Amebocyte Lysate Test'?
What was the purpose of the last guidance document mentioned in the text, 'Guideline on Validation of the Limulus Amebocyte Lysate Test'?
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What did FDA's 1983 guidance suggest about the use of LAL test for endotoxins?
What did FDA's 1983 guidance suggest about the use of LAL test for endotoxins?
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