In order to view the video portion of this training, the following are required:
If you are unable to meet the above requirements, you also have the following options:
After completing the training, please reference the following links for more resources:
For more information, please consult our Technical Support section.
Key Points
Audio Transcript
You will need to do some work before you get started. Based on the decision tree pathways we just reviewed, you will need to identify which office within the FDA will likely review your product. The Office of Generic Drugs, or OGD, will review an ANDA product. The Office of New Drugs, or OND, will review an NDA for a prescription drug product. The Office of Nonprescription Products (ONP) will review an NDA for an OTC drug product. If you have questions as to whether your product is legally marketed, contact CDER's Office of Compliance, Division of New Drugs and Labeling Compliance. Contact information can be found in the Resources Tab.