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Key Points
Audio Transcript
We strongly encourage you to familiarize yourself with the FDA's IND/NDA process at the FDA. We have included some links to web-based information in the Resources tab of this module. There are certain procedures that must be followed in the Drug Application Process and specific data and information that must be provided to support the approval of any drug product. We encourage you to utilize the information provided on the Center for Drug Evaluation and Research website to become familiar with this process prior to submitting your request for a meeting. Click the links to the left to access information about how to navigate the drug approval process.