Priority review

Priority review is a designation given by the Food and Drug Administration (FDA) to a drug that, if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition. This designation is intended to direct overall attention and resources to the evaluation of such applications.

Overview

The Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services that is responsible for protecting and promoting public health. One of the ways it does this is by reviewing new drugs before they can be sold to the public. The FDA's review process is designed to ensure that new drugs are safe and effective for their intended use.

A "priority review" designation means that the FDA aims to take action on an application within six months, compared to ten months under standard review. This does not guarantee approval within six months, but it does mean that the FDA will make a decision more quickly.

Criteria for Priority Review

The FDA grants priority review status to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal is to get important new drugs to the patient earlier. To qualify for priority review, a drug must meet one of the following criteria:

• It treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
• It offers major advances in treatment, or provides a treatment where none existed.

Impact of Priority Review

The impact of a priority review designation can be significant. It can lead to faster approval of a drug, which can mean that patients have access to important new treatments more quickly. It can also lead to increased attention and resources being directed towards the evaluation of the drug.

See Also

• Food and Drug Administration
• Drug Approval Process
• New Drug Application

Priority review Resources
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