---
title: "Priority review"
slug: "priority-review-1"
updated: 2025-02-26T15:10:59Z
published: 2025-02-26T15:10:59Z
canonical: "bgtcplaybook.document360.io/priority-review-1"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Priority review

A Priority Review designation means the FDA’s goal is to act on an application within 6 months of filing by the FDA. A drug, including those that received Fast Track, Breakthrough Therapy, or RMAT designation, may be eligible for Priority Review, if it meets the criteria for Priority Review at the time the marketing application is submitted. A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. [[9]](/v1/docs/ref-program-selection)

At the time of a pre-biologics license application (pre-BLA) meeting with CBER, sponsors of regenerative medicine therapies, including those under expedited development programs, should consider discussing their eligibility for Priority Review. A regenerative medicine therapy may receive Priority Review if it treats a serious condition, and, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of the condition.

Regenerative Medicine Advanced Therapy (RMAT) - https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation

Center for Biologics Evaluation and Research (CBER) - The Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.