Would it be fair for the FDA not to approve an NDA application with good clinica
Would it be fair for the FDA not to approve an NDA application with good clinical data but poorly written Module 2-5 sections? 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?2 pages needed Requirements: As above   |   .doc file

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