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Item 2 Labeling Labeling is item 2 on page 2 of FDA Form 356h. You should provide the labeling as described in the NDA guidance. E. Item 11 Case Report Tabulations CRTs CRTs are item 11 on page 2 of FDA Form 356h. follow the NDA guidance on the format and documentation of the datasets. The NDA guidance provides specific recommendations on the individual items on FDA Form 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Hum...

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