Federal Circuit Reaffirms Deferential OCI Standard
Client Alert | 1 min read | 05.06.09
The Federal Circuit in Axiom Resource Mgmt., Inc. v. U.S. (May 4, 2009) reversed the CFC decision granting a protest on the basis of an organization conflict of interest ("OCI"), and, in doing so, reaffirmed that, when the CFC reviews an OCI determination by a CO, including, in this case, the adequacy of a mitigation plan, it must apply the deferential "arbitrary and capricious" standard of the Administrative Procedure Act. In addition, the appellate court criticized the CFC for accepting litigation affidavits and relying on them when there was no need to supplement the administrative record, along the way casting doubt on the vitality of the Esch factors commonly used by the CFC in deciding whether to supplement an agency record in a bid protest case.
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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.
Client Alert | 2 min read | 05.09.25
New SF-328 for Foreign Ownership, Control, and Influence Assessments Approved, Publication Imminent
Client Alert | 4 min read | 05.08.25
Client Alert | 4 min read | 05.07.25
