In the U.S. Food and Drug Administration (FDA) regulations, an investigational new drug is:A. No substance seeking FDA approval.B. Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought.C. Generic of a �branded� drug.D. All of the above.
Question
In the U.S. Food and Drug Administration (FDA) regulations, an investigational new drug is:A. No substance seeking FDA approval.B. Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought.C. Generic of a �branded� drug.D. All of the above.
Solution
The correct answer is B. Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought. According to the U.S. Food and Drug Administration (FDA) regulations, an investigational new drug is a new substance that is being tested and is seeking approval from the FDA. This can include a new drug, vaccine, or biological product. It does not include substances that are not seeking FDA approval or generic versions of already approved drugs.
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