A safety report required in the United States 4 months after CTD submission (including IAS – Integrated Analysis of Safety) of an application for marketing approval, and before the New Drug Application (NDA) is approved. The 120 Day report contains any new safety information learned about the drug that may reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the draft labeling (21CFR§314.50(5)(vi)(b)(April 2014).
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