When and how often must an applicant submit an annual status report to FDA?
An applicant must submit an annual report each year within 60 days after the anniversary date of U.S. approval of the application. The annual status report is required for all applications with open requirements and commitments until we notify the applicant, in writing, that all postmarket study commitments established under the application(s) have either been fulfilled or that the applicant is released from the commitments. The annual report due date will be based upon the anniversary date for the original application approval date. Separate annual reports are not required for supplemental applications. An annual status report can address more than one commitment for a particular NDA, BLA, or ANDA.
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