Health And Medical Question Assignment Paper

I need an explanation for this Health & Medical question to help me study. Would it be fair for the FDA not to approve an NDA application with good clinical data but poorly written Module 2-5 sections?

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Conversely, would it be fair for the FDA to approve an NDA application on the basis of well written Modules but marginal data?  What factors must be considered in each of these situations?  Health And Medical Question Assignment Paper