Read 21 CFR 312 regarding content of IND's and then read 21 CFR 314.50 regarding information required in applications for FDA approval to market a new drug. Animal testing is needed. Just one part of the regulation if you do not want to read it all: A description and analysis of each clinical pharmacology study of the drug, including a brief comparison of the results of the human studies with the animal pharmacology and toxicology data.
Think about why drugs, medical devices, etc are so expensive... takes years and millions of dollars to get something approved.... and then millions more spent on marketing and post approval studies.
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