FDA Expands Expiration Date on Dispute Resolution Guidance
The FDA has refreshed its guidance on formal dispute resolution, extending the guidance’s expiration date until March 31, 2022.
The guidance, initially published in 2017, was set to expire on May 29, but the agency tacked on three years. It gives rules of the road for sponsors to appeal decisions from CDER and CBER that can’t be settled at the division level.
The agency promises to respond to appeals within 30 days for disputes involving IND, NDA or BLAs, as well as biosimilars.
Sponsors can go through formal dispute resolutions after they receive complete response letters, clinical trial holds, denials of breakthrough designation, proprietary name review, and when the agency refuses to receive an ANDA.
But both CDER and CBER suggest that sponsors ask the individual divisions to review their cases before formally appealing.