FDA updating dispute resolution guidance

FDA published draft guidance on Tuesday that will update the process to resolve scientific and procedural disputes for drugs and biologics that cannot be resolved at the division level. The draft is mostly in line with and will replace guidance published in February 2000.

According to the draft guidance, a sponsor may submit a request for formal dispute resolution to appeal a decision made by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) while reviewing a product. Requests made to CDER should be submitted as an amendment to the original application, while requests to CBER should be submitted to the CBER ombudsman. All requests should include a brief statement of the issue, the steps that have been taken to resolve the issue and possible solutions. The sponsor may also request an advisory committee meeting to discuss the issue. ...