FDA Releases Guidance on Formal Disputes

FDA released guidance on Sept. 8, 2015 providing recommendations for resolving scientific and/or medical disputes that may arise during review of investigational new drug applications, new drug applications, biologics license application, or abbreviated new drug applications, including procedures for formally appealing issues to the office or center level and procedures for resolving disputes.  FDA states that due to the complex scientific nature of some disputes, “it is critical to have procedures in place to help ensure open, prompt discussion of such disputes. The procedures and policies described in this guidance are intended to promote rapid resolution of scientific and/or medical disputes between sponsors and CDER [Center for Drug Evaluation and Research] or CBER [Center for Biologics Evaluation and Research].”

The guidance is a revision of a March 2013 guidance and includes formal dispute resolution requests (FDRRs) for human drug applications covered under the Biosimilar User Fee Act of 2012 (BsUFA). The guidance clarifies when a matter is and is not appropriate for an FDRR, information to include in the supporting background information, and that “CDER and CBER intend to manage formal requests for appeals of scientific and/or medical disputes related to an application for a user fee product under any of the available regulatory mechanisms (i.e., 21 CFR 10.75, 312.48(c), 314.103(c)), through the FDR process.”

Source: FDA