CBER Revises Policy on Formal Dispute Resolution

CBER has issued a revised a Standard Operating Policy and Procedure (SOPP) on “SOPP 8005: Formal Dispute Resolution Process,” which describes the policy for resolving procedural or scientific disputes that cannot be resolved at the review division level between sponsors and CBER review staff regarding submissions under review. The document also describes the timeframes for a response from CBER to an appeal and for a follow up appeal.

According to the SOPP, CBER is “committed to resolving scientific and procedural differences with sponsors as quickly and amicably as possible through the cooperative exchange of information. Differences with sponsors will be addressed at successively higher levels of the chain of command at the request of the sponsor or until resolution is achieved.” The policy notes that issues not resolved at one level be appealed, in writing, to the next level in the chain of command. Additionally, all formal dispute resolution requests should be coordinated by the CBER Ombudsman.