Pre-Award Protest Timeliness Rule Extended
Client Alert | less than 1 min read | 12.18.12
In Comint Sys. Corp. v. U.S. (Dec. 7, 2012), the Federal Circuit extended its judicially imposed timeliness rules to require a protest of a solicitation defect to be filed in court prior to award, if practical, even if the alleged error occurred after proposals had been submitted. The court noted that this is consistent with the GAO timeliness rules.
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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
