On December 12, 2025, GAO released its Bid Protest Annual Report to Congress for Fiscal Year 2025, which provides bid protest statistics and other information regarding GAO’s protest system.
European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines
This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.
On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech sector and accelerating the development
The Proposed EU Biotech Act Aims to Accelerate and Streamline Procedures for the Approval of Clinical Trials and Combined Studies
This is one in a series of Inside European Life Sciences blogs on the proposal for an EU Biotech Act in the form of a regulation that the European Commission released on 16 December 2025. This blog focuses on the proposals to amend the EU’s clinical trial rules and establish a new regime for combined
EU Deforestation Regulation Postponed and Simplified: What Companies Need to Know
European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations
The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission aims to make the rules
RESourceEU Action Plan – Strengthening the EU’s Access to Critical Raw Materials
On 3 December 2025, the European Commission adopted the RESourceEU Action Plan, signaling that Europe’s industrial competitiveness will increasingly depend on its ability to secure and diversify critical raw material (“CRM”) supply chains. For companies, inside and outside the EU, RESourceEU is more than a technical update: it marks a policy shift toward a
FY26 NDAA Aims to Raise the Dollar Thresholds for the Applicability of CAS and TINA
Among the most challenging areas of regulatory compliance for federal contractors are cost accounting and cost and pricing data disclosure requirements. Indeed, many companies place guardrails on the nature and scale of their business relationships with the U.S. government precisely to avoid the application of these requirements. In a move that seems consistent with the
CJEU Clarifies Responsibilities Of Online Marketplace Operators
On December 2, 2025, the Court of Justice of the European Union (“CJEU”) issued a decision clarifying the obligations of online marketplace operators with regard to content posted on their platform, where such content includes personal data. This blogpost provides an overview of the decision and its key takeaways.
Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media
In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second, the court treats promotional social media reels/videos
President Trump Signs Executive Order to Block State AI Laws
On December 11, President Trump signed an Executive Order on “Ensuring a National Policy Framework for Artificial Intelligence” (“AI Preemption EO”), the culmination of months of efforts by Republican lawmakers to assert federal primacy over AI regulation. The AI Preemption EO, which follows the release of a draft version in November, states that “[t]o win”