CBER Updates Process for Formal Disputes With Sponsors

CBER has updated its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised procedures and adding medical devices to the formal dispute resolution process.

The updated SOPP 8005: Formal Dispute Resolution Process applies to disputes between sponsors and CBER review staff involving regulatory submissions. Under the process, sponsors can appeal unresolved issues in writing to successively higher levels of CBER management. It can ultimately proceed through FDA's chain of command to the FDA commissioner.

The revised procedure assigns the CBER Ombudsman responsibility for coordinating formal dispute resolution requests, including preliminary review, routing, tracking and communication with sponsors. The Center encourages sponsors to consult the Ombudsman before filing a formal request in an effort to resolve issues informally