What document is submitted to the FDA that includes animal study results and plans for human studies?

The correct document that is submitted to the FDA, which includes results from animal studies and outlines the plans for human clinical studies, is the Investigational New Drug application (IND). The IND is crucial for initiating clinical trials in humans as it provides the FDA with essential information regarding the drug's safety, pharmacological effects, and the proposed study protocols.

In the IND application, the sponsor must detail the findings from preclinical (animal) studies to demonstrate a reasonable safety profile before moving on to human trials. This ensures that the potential risks to human participants are understood and managed appropriately. The plans for the human studies, including their design, methodology, and how safety will be monitored, are also necessary components of the IND.

Other options play distinct roles in the drug development and approval process. The New Drug Application (NDA) is submitted after clinical trials to request approval for marketing a drug based on data collected, while the Abbreviated New Drug Application (ANDA) is used for generics and references a previously approved drug. The Biologics License Application (BLA) is specific to biological products and does not pertain to the initial stages before clinical trials commence. Therefore, the IND is the appropriate choice when defining submission involving animal study results and plans