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Key Points
Audio Transcript
Hello, and welcome to CDER's Bringing an Unapproved Drug into Compliance educational presentation. My name is Maria Aselage, and I am here to walk you through the fundamentals of the FDA drug approval process.
We hope that you will take the time to go through each of the topics, use the resources tab to access specific information and instructions about the drug approval process, and more importantly, refer back to this training any time you have a question or concern about how to obtain FDA approval for manufactured drugs.
The primary goal of the Bringing an Unapproved Drug into Compliance training is to engage manufacturers of drugs marketed without FDA approval or compliance with an OTC monograph. We then would like to explain the FDA's policies and practices regarding marketed unapproved drugs, and finally, we want to help you take the appropriate steps to get your product through the approval process.
Once you have completed this training activity, you should be able to:
- explain the difference between GRASE, grandfathered, and DESI-pending products;
- describe three pathways for obtaining FDA approval for a drug product; and identify the appropriate points of contact within FDA to help with your drug application and approval process.