Unduly Restrictive Specification Requires Redo
Client Alert | less than 1 min read | 03.24.15
In Smith and Nephew Inc. (Jan. 2, 2015), publicly released this week, GAO sustained a pre-award solicitation protest alleging that the VA had unduly restricted competition with an unnecessary specification requirement. GAO concluded that the "minimum fluid absorption rate" for medical bandages demanded by the VA was not based on any demonstrable agency need, was predicated on one repudiated test study by a single contractor, and could not be met by any commercially available product in the marketplace.
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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
