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A Rose and a Thorn: Federal Circuit Permits Contractor to Add New Claim to Pending Complaint, but Enforces Notice Provision to Bar Recovery

Client Alert | 1 min read | 02.26.15

In K-Con Building Systems Inc. v. United States, the Federal Circuit held that a contractor could amend its COFC complaint to add new, denied claims related to the appeal if the new claims either requested different remedies (e.g., additional compensation, remission of funds, non-monetary relief) or asserted legal grounds for relief that were materially different from the claims under appeal. This holding may prove helpful to contractors at the COFC who identify additional bases for recovery/remedies after filing their complaint; however, the Court also denied recovery because the contractor's two-year delay before notifying the government of the alleged "changes" failed to provide the adequate notice required by the Changes Clause, distinguishing the facts in K-Con from those in prior cases where notice provisions were not strictly enforced.

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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....