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Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. Page 4 REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. In addition under 21 CFR 314. 81 b 2 vii and 314. 81 b 2 viii you should include a status summary of each commitment in your annual report to this NDA. Pdf. As required under 21 CFR 314. 81 b 3 i you must submit final promotional materials and the package insert at the time of initial dissemination or publication...
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