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FEATURE COMMENT: COFC Pushes Back on GAO Waiver and Cost-Realism Analyses

Client Alert | 1 min read | 10.14.21

In a recent alert, we highlighted VS2 v. U.S., in which theCourt of Federal Claims refused to expand the Federal Circuit’s Blue & Gold waiver doctrine and required the Army to consider performance risk in a cost realism evaluation. In a new “Feature Comment” published in The Government Contractor, we take a deeper dive into the Court’s disagreement with GAO and what it means for contractors and agencies going forward. Of particular note, contractors considering capping costs in their proposals should carefully consider when and how agencies may evaluate performance risk; and both protesters and intervenors must stay vigilant and diligently pursue potential protest grounds.

Insights

Client Alert | 2 min read | 05.09.25

FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization....