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The following template provides guidance for preparing this annual report. FDA requires a response to every question outlined at 21 CFR 312.33, Sponsor: Sponsor/Investigator Name 201X Annual Report The original IND XX,XXX was submitted to the FDA on Date. This annual report summarizes data for We also have orphan drug designation within FDA (same indication) and as I can understand we should only submit one annual report ( EMA/121846/2010) Statement of Commitment: [For agent-submitted annual reports, the following statement of commitment, signed by the DMF holder, should be included in this letter Please note that all Duke-sponsored regulatory submissions to the FDA (or other IND Maintenance Cover Letter Template · IND Annual Report Template The NDA/ANDA/AADA holder should follow the procedure outlined in Form FDA 2252 when filing an Annual Report. Annual Reports should be filed for all approved Drug Administration's (FDA) Center for Biologics Evaluation and Research's (CBER) process to obtain annual reports for all active investigational new drugTransmittal letter introducing original IND submission. ☐. Cover Sheet (FDA 1571). FDA Form 1571, ☐. Table