Annual Report

[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers. These reports must be filed each year within 60 days of the anniversary date of the drug’s approval, and accompanied by an FDA Form 2252, Transmittal of Periodic Reports for Drugs for Human Use. These reports are generally produced by electronic publishing of the required components.


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