Can research standards be appropriately lowered for drugs that be granted priority review designation?

Priority review is intended to expedite the FDA's review of new drugs and vaccines that have the potential to offer significant improvements over available therapies for serious conditions. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary. The agency carefully evaluates the quality and integrity of the clinical trial data submitted by the sponsor, and may require additional information or studies if necessary. Overall, priority review is designed to accelerate the approval process for promising new treatments while still ensuring that these medications meet the same rigorous standards for safety and efficacy as other drugs. Under priority review, the FDA may provide additional resources and support to facilitate the review process and The priority review policy only shortens the time frame for the review.