FDA Guidance Outlines Formal Dispute Appeal Process

The FDA published a guidance for industry and its reviewers on the formal CDER and CBER procedures for resolving scientific disputes with sponsors that cannot be settled at the division level, and how to appeal issues to the office or center levels.

For disputes affecting an IND, NDA or BLA, as well as biosimilars and generics, the agency’s goal is to respond to appeals within 30 calendar days.

Formal dispute resolution requests are acceptable following complete response letters, full or partial clinical holds, denials of breakthrough therapy designations or proprietary name reviews, and if the agency refuses to receive an ANDA.

CDER and CBER recommend that sponsors ask the review division to reconsider the issue before making a formal appeal to a higher level.