FDA Releases Guidance on Resolving Issues with the Agency

News
Article

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

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.