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# Guide on Good Review Management Principles
- URL: https://www.fdaweb.com/guide-on-good-review-management-principles/
- Published: 2018-09-24T12:00:00.000Z
- Updated: 2026-09-15T00:33:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142420

FDA has posted a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079748.pdf?ref=fdaweb.com) entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” The document is intended to provide recommendations to industry and review staff to ensure that the review process is managed in a consistent and efficient manner, thereby decreasing the number of review cycles necessary for approval. It also clarifies the roles and responsibilities of review staff in managing the review process and identifies ways in which applicants may support an efficient and robust review process. For example, the guidance says that effective interaction between FDA and applicants during product development is critical to maximizing first-cycle review efficiency.

The document notes that there are important reasons for applicants to discuss development plans with FDA and consider the review team’s feedback. “Review staff can provide valuable scientific and regulatory advice to the applicant, including helping advise applicants on the level of evidence needed to demonstrate the product’s safety, efficacy, and quality,” it says. “Open communication between FDA and applicants should occur at pivotal points during product development. This communication can lead to identification of potential filing and review issues that the applicant should address before submission of a marketing application. Development milestones should be marked with meetings between FDA and applicants to exchange ideas on development program status and planning.”

And, FDA says, applicants should promptly inform review divisions when issues arise during development that may affect product approval (e.g., inability to carry out agreed-upon protocols, new nonclinical or clinical safety concerns, manufacturing problems). “Taking timely and appropriate action on this information can help prevent deficiencies that could cause FDA to refuse to file an application or result in additional review cycles,” it adds.