FDA Releases Guidance on Resolving Issues with the Agency
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
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.
Source: FDA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
