FDA Releases Guidance on Resolving Issues with the Agency

On October 11, 2017, FDA published guidance on how applicants of abbreviated new drug applications (ANDA) can resolve scientific and/or regulatory problems with FDA and request review reconsideration. The guidance, however, does not detail the formal dispute resolution procedure or the procedures for resolving administrative issues.

ANDA applicants may sometimes disagree with FDA regarding scientific or regulatory issues that are an important part of product evaluation. The agency states in the guidance that it is “critical” to have policies and procedures to consider the concerns of applicants. The guidance formalizes FDA’s current and past practices as a way to promote fair and quick resolution of these disputes.