Which item is a component of the NDA package?

• A. Index
• B. Marketing plan
• C. Advertising copy
• D. Patent landscape

Answer: (A)

The main thing being tested is how the NDA submission is organized for regulatory review. A properly prepared NDA package starts with an index (a table of contents) that maps every section and document—administrative information, summaries, nonclinical and clinical data, chemistry, manufacturing and controls, labeling, and more—so reviewers can quickly locate what they need. This navigational tool keeps the huge, complex file manageable and ensures nothing important is overlooked.

Marketing plans and advertising copy belong to commercialization and promotional activities, not the regulatory review process. A patent landscape is an IP analysis rather than a core part of the submission content, though patent status might be noted separately. Because the NDA package fundamentally relies on a clear index to organize the submission, it is the component that truly fits.