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Key Points
Audio Transcript
Now let's look at the New Drug Application, or NDA section of the unapproved drug decision tree. We are speaking of the section on the right side of the decision tree that is colored in green.
If the active ingredient in your product does not already have an NDA or ANDA approval, and your drug is NOT being reviewed under the OTC Drug Review System, then you will likely need to submit an NDA. The Office of New Drugs is responsible for the oversight of investigational new drugs. This office is also responsible for the approval decisions on new drug applications.