Yes. As stated in the Commitment Letter, any Tier 1 amendment that requires an
inspection will have a goal date of 10 months from the date of its submission.
Further, to ensure that the Agency has enough time to review any major application
changes, FDA has the discretion to change the classification of an amendment
based on the type, quantity, and complexity of data submitted. For example, a
complete response (CR) letter will advise the applicant whether the CR amendment
(or CR response) will be classified as a major or minor amendment. However, if
the applicant submits a CR amendment that contains additional information or data
beyond what was identified in the CR letter as necessary to correct the deficiency or
deficiencies, FDA may change the classification of the amendment from a Tier 1
solicited major or minor amendment to a Tier 2 unsolicited amendment.