Draft Guidance Aids in Writing NDA, ANDA Drug Component List to Speed Approval

Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs.

The six page draft guidance, “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling,” describes best practices for writing the composition statement and statement of ingredients in the labeling and recommends how to provide complete information and ensure product labels are written clearly.

This guidance also includes examples of “common, recurring problems identified during FDA’s preliminary and substantive assessment” of the content and format of the composition statement and the corresponding statement of ingredients in labeling. Comments on the draft are due by June 24.

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