Price Realism Requirement Must Be Stated to Allow Unacceptability Finding
Client Alert | 1 min read | 11.25.15
In W.P. Tax & Accounting Group (Nov. 13, 2015), GAO reminded agencies that, in fixed-price procurements, below-cost pricing is not inherently improper and cannot serve as the basis for a technical unacceptability finding when the solicitation does not provide for a price realism evaluation. Because the solicitation in W.P. said nothing about a price realism evaluation, GAO overturned the agency's rejection of the low-priced vendor's quotation as technically unacceptable and recommended that the agency either reevaluate the vendor's quotation against the stated evaluation criteria or amend the solicitation to provide for a price realism evaluation.
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Client Alert | 7 min read | 01.10.25
New Draft Guidance From FDA Explains When an Accelerated Approval Trial Is “Underway”
On January 6, with increased attention and scrutiny from patients, providers, developers, and payors on the accelerated approval pathway for drugs, the Food and Drug Administration (FDA) released new draft guidance for industry on what it means for a drug’s confirmatory trial to be “underway” under section 506(c) of the Federal Food, Drug, and Cosmetic Act.
Client Alert | 11 min read | 01.10.25
Client Alert | 7 min read | 01.09.25
Navigating Disputes on Megaprojects Amid Trump Tariffs - Part 2
