TINA Threshold Raised but Broader Data Requests Likely
Client Alert | 1 min read | 10.05.10
Effective October 1, a "clarified" FAR regulation regarding compliance with the Truth in Negotiations Act raises the threshold for providing certified cost or pricing data from $650,000 to $700,000 for covered contract and subcontract awards and modifications. The new regulation, which the Civilian Agency Acquisition and Defense Acquisition Regulations Councils say merely contains clarifications and "neither expands nor diminishes the existing right of contracting officers to request cost or pricing data whether certified or other than certified" appears likely to precipitate expanded and more aggressive contracting officer requests for non-certified judgmental data, even when certified cost or pricing data are required, and, particularly with respect to "excepted" procurements for commercial items and services, for (non-certified) cost data.
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Client Alert | 3 min read | 06.30.25
The New EU “Pharma Package”: Preparing for the Trilogues
On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.
Client Alert | 3 min read | 06.26.25
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
Client Alert | 3 min read | 06.26.25
Client Alert | 4 min read | 06.26.25
Ninth Circuit Affirms that CIPA Only Applies to Third-Party Eavesdropping
