This revised Draft Guidance on Reconsideration of Decisions Issued for Human Drug Submissions is intended to describe the appropriate process to address submission-related disputes and reflect a more transparent and impartial Reconsideration Process. Key changes to this revised version include administrative changes, including the transfer of “responsibility for the management and administration of this process” to the Food and Drug Act Liaison Office and the exclusion of reconsiderations under this policy of Priority Review Requests, and Requests for Advance Consideration.
Sponsors are permitted to file a Request for Reconsideration following a number of decisions, including but not limited to (the guidance lists 7 examples):
- Notice of Deficiency – Withdrawal Letter
- Notice of Non-compliance – Withdrawal Letter
- Rejection of Accelerated Licence Amendment Submission
An important note regarding the “Reconsideration Process is that it is not intended to circumvent the established process for refilling a submission, thus new data will not be considered…” A comprehensive map of the Reconsideration Process is included in the guidance as Appendix A (found on pages 13-14 of the PDF version).
Pages 2 through 5 outline the responsibilities for various parties that may be involved in the Reconsideration Process and the actual Reconsideration will be completed by persons not involved with the original decision. The guidance goes on to detail Reconsideration Process implementation and formatting.
This revised guidance has been released for a 60 day consultation period – once finalized it is scheduled to replace “the 2006 Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions” and is scheduled to become effective as of January 1, 2015.
The revised guidance document and directions on how to submit comments can be accessed here: