`
`Priority Review | FDA
`
`Priority Review
`
`Prior to approval, each drug marketed in the United States must go through a detailed FDA
`review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific
`goals for improving the drug review time and created a two-tiered system of review times –
`Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to
`take action on an application within 6 months (compared to 10 months under standard review).
`
`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.
`
`Significant improvement may be demonstrated by the following examples:
`
`evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;
`
`elimination or substantial reduction of a treatment-limiting drug reaction;
`
`documented enhancement of patient compliance that is expected to lead to an
`improvement in serious outcomes; or
`
`evidence of safety and effectiveness in a new subpopulation.
`
`FDA decides on the review designation for every application. However, an applicant may
`expressly request priority review as described in the Guidance for Industry Expedited Programs
`for Serious Conditions – Drugs and Biologics. It does not affect the length of the clinical trial
`period. FDA informs the applicant of a Priority Review designation within 60 days of the receipt
`of the original BLA, NDA, or efficacy supplement. Designation of a drug as “Priority” does not
`alter the scientific/medical standard for approval or the quality of evidence necessary.
`
`https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
`
`1/1
`
`UPenn Ex. 2009
`Miltenyi v. UPenn
`IPR2022-00853
`
`
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