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Key Points
Audio Transcript
It is not FDA's practice to provide extensive advice regarding clinical trial design or the necessary details of a drug development program via email or phone outside of a multidisciplinary team review and discussion on the specific topic. That is why we encourage sponsors to request and attend a pre-IND meeting.
We welcome having a discussion with you on your proposal. We encourage you to provide us with as much information as you can regarding your proposal to allow us to address your questions and provide you with advice.
We hope this information is helpful to get you started.In summary, it is important to determine whether or not your marketed product has been approved by the FDA. Products marketed without FDA review could pose a significant health risk to people taking them. FDA is taking strong steps to bring unapproved drugs into the approval process. Any product that is being marketed illegally is subject to FDA enforcement action at any time. The good news is that, as demonstrated in this course, there are several ways drugs can be legally marketed.
We hope you have enjoyed this educational session. If you have questions or would like more information regarding the application process, please contact the Unapproved Drugs Coordinator in the Office of New Drugs at 301-796-0700. Thank you.