Today we address what might seem like an ongoing problem with no end. I refer to the submission of unsolicited amendments by DMF holders during an ANDA review cycle. If the DMF holder is unaware of the status of an ANDA and they do submit an unsolicited amendment, it could delay the review cycle or result in a complete response letter to the ANDA sponsor because of the timing of the submission of a DMF amendment. FDA has noted that “[P]oorly timed unsolicited amendments continue to adversely impact application timelines” and the worst part is that “the unsolicited amendment may not be necessary at the time they are submitted.”
One of the FDA presentations by CAPT Craig Kiester, RPh, MS, Director, Division II, Office of Program and Regulatory Operations OPQ/CDER/FDA provides the following advice and it all relates to closer communication between the DMF holder and ANDA applicants.
DMF holders and applicants should share the following information in a timely way:
– Plans to submit changes to the DMF
– Key expected action dates and priorities for the referencing application(s)
– Know the current status of your DMF – FA letters, NFC letters, real time updates from
If it is not clear whether an unsolicited DMF submission will impact an application timeline, do the following:
– Reach out to your customers to get information on application timelines
– Reach out to DMFOGD so we can provide helpful guidance on submission timing
Understand the consequences of a poorly timed DMF amendment to your customer’s ANDA
– Goal date extension (extended from the date the DMF amendment is received)
– Length of extension determined by nature of the amendment (major or minor)
– Potential loss of an exclusivity (forfeiture date)
– Withdrawal of a DMF amendment will not restore an already extended goal date
As noted above this is not a new problem, but it is recommended that active and frequent communication with your DMF holder is the best way to mitigate potential unintended additional review cycles or ANDA approval.
