So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?

If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help your product move smoothly through the submission process and on to premarket approval.