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Title Vol Chapter Part 21 5 I 312.42 (a) (1) (i) (A) ( 1 ) |
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e-CFR citation heirarchy I have a hard time following the CFR heirarchy. I don't know the name for all of these (sub-part, sub-paragraph, etc.) This is the furthest I've been down. |
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| Common Technical Document |
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What part of 21 CFR contains regulations relevant to NDA filing and content? |
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What does BLA mean? What part of 21 CFR contains regulations relevant to BLA filing and content? |
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Biologics License Application 21 CFR 600 |
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| Chemistry and Manufacturing Controls |
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| What part of 21 CFR contains regulations relevant to IND filing and content? |
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| What international document is the basis for informed consent regulations? |
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Declaration of Helsinki based on Nuremburg Code and Declaration of Geneva |
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| Which part of 21 CFR contains the regulations relevant to electronic data capture of clinical trial data? |
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| What is the abbreviation for the legislation that defines review deadlines for FDA, and results in companies paying fees for filing applications and for annual establishment and product fees? |
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PDUFA Prescription Drug User Fee Act |
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