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  • I am going through the RAPS course materials for Intermediate Medical Writing. The lesson on the CTD details sections in a "marketing application." The next lesson details sections of the "New Drug Application," which are the same, and which the course refers to as the "marketing application" within the module. Is there a difference? Also, when submitting...

  • Annette, As for moderate changes (CBE-0 and 30), FDA's current policy is that "if a change is considered to be moderate, an applicant must submit a supplement at least 30 days before the product is distributed (CBE-30 supplement) or, in some cases, submit a supplement at the time of distribution (CBE-0 supplement)." David ------Original...

  • I think there is also a good chance that if you filed as a CBE-0/CBE-30 and FDA reclassified as Prior Approval that you would hear from FDA within 30 days notifying you of the reclassification. They may even ask you to resubmit as a Prior Approval. Tom Chicago ------Original Message------ I am interested in learning more about...

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