In February 2000, FDA released a draft guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level” which established procedures for resolving scientific and procedural disputes that were unable to be resolved at the division level. In March 2013, the Agency published a revised version of the guidance. One important modification was the extent to which FDA emphasizes new information or analyses, stating they should not be submitted to the Agency as a part of a formal dispute resolution request (FDRR). Additionally, it specified that, if the issue(s) being appealed are also being review by the division, FDA will not review the FDRR.
Last week, FDA announced a second updated version of the draft guidance. The updates include additional details concerning supporting background information, as well as clarity with regards to when an FDRR is necessary. The revised version states that sponsors of biosimilar products can have the same process for raising a dispute as other companies file various submissions (e.g., INDs, NDAs, BLAs, and ANDAs), which is significant given the recent attention biosimilar products have received.
The guidance provides information regarding appropriate matters for submitting an FDRR, providing examples of regulatory actions that are appropriate. The examples provided include:
- “Complete response (CR) letter
- IND clinical hold (partial or full)
- Request for breakthrough therapy designation denied
- Request for proprietary name review denied
- Refuse to receive for an ANDA.”
Additionally, the updates include the procedures to follow when submitting an FDRR, an outline of the necessary content and format of an FDRR, information for responding to an appeal, and much more. For the full contents of the document and more additional details, view the full guidance here.