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Recent changes
LB1165 - Income Tax Credits and Employer Retention Grant Programs
Nebraska's LB1165, the Grow the Good Life Act, has been enrolled by the 109th Legislature after passing both chambers. The bill introduces income tax credits and creates grant programs to help employers retain or attract employees, and to assist cities of the first class impacted by private entity closure or downsizing. It also modifies provisions of the Convention Center Facility Financing Assistance Act, ImagiNE Nebraska Act, Nebraska Advantage Act, and Site and Building Development Act. The bill now awaits gubernatorial action.
HB1228 - Alimony Enforcement Amendment
New Hampshire House Bill HB1228 passed the House on March 6, 2026. The bill addresses enforcement of alimony orders and has been referred to the Senate Children and Family Law Committee. The legislation passed with strong committee support (15-0 in House, 3-0 in Senate) and awaits further Senate action.
Securitisation market diversifies; residential mortgages lose their dominance
DNB published statistical data showing the composition of the Dutch securitisation market has shifted significantly between 2020 and 2025. The share of non-mortgage loans in securitisations rose from 12% to 29%, with outstanding volume almost doubling to €8.5 billion. This growth was driven by non-bank entities including consumer credit companies and leasing firms securitising car loans, consumer loans, and SME equipment leases.
EU Design Act strengthens medical device design protection
Hogan Lovells analyzes the EU Design Act (effective May 1, 2025 with further reforms July 1, 2026) and its implications for medical device manufacturers. The reform extends design protection to digital and dynamic elements, strengthens enforcement against unauthorized digital replication and 3D printing, and addresses the repair clause for spare parts.
Trump Administration Announces Tariffs on Imported Patented Medication and Pharmaceutical Ingredients
Mayer Brown summarizes the Trump Administration's April 2, 2026 proclamation imposing sweeping tariffs on imported patented medications and active pharmaceutical ingredients (APIs) under Section 232 of the Trade Expansion Act of 1962. The proclamation establishes a 100% ad valorem duty on products of companies without approved MFN pricing or onshoring agreements, effective July 31, 2026 for non-compliant companies and September 29, 2026 for others. The tariffs are justified on national security grounds, citing that 53% of US patented pharmaceuticals and 85% of patented APIs were produced abroad as of 2025.
FDA Grants Limited Enforcement Discretion for CBD Dietary Supplements
The FDA announced a new enforcement discretion policy for orally administered, hemp-derived CBD products effective April 1, 2026. The policy only applies to CBD dietary supplements meeting four criteria and provided to Medicare beneficiaries at the direction of a treating physician. CMS has established a Substance Access BEI program allowing participating organizations to offer up to $500 per year of hemp products to eligible Medicare beneficiaries.
FDA clarifies compounded GLP-1 policies, warns telehealth companies
FDA clarifies compounded GLP-1 policies, warns telehealth companies
CMS ACCESS Model and FDA TEMPO Pilot: Outcome-Based Payments and Digital Health
Offit Kurman analyzes CMS's ACCESS Model (a CMMI initiative) testing outcome-aligned payments tied to measurable clinical improvements for Medicare Part B providers, running concurrently with FDA's TEMPO pilot supporting digital health technology integration. The article details participation requirements, payment structures involving 50% upfront and 50% withheld amounts subject to reconciliation, and FDA enforcement discretion possibilities for digital health devices used within the model.
CMS Reaches $100 Million in Stark Self-Disclosure Settlements
CMS released 2025 settlement data for voluntary self-disclosures under the physician self-referral law (Stark Law), settling 244 cases totaling over $20.4 million. Aggregate settlements since the SRDP's inception in 2011 have now exceeded $105 million. A record single settlement of $2.68 million more than doubled the previous high from 2018.
FDA Draft Guidance on 483 Responses for Drug Manufacturers
Cooley LLP summarizes FDA's new draft guidance providing, for the first time, formal recommendations for drug manufacturers on responding to Form FDA 483 observations following cGMP inspections. The guidance applies to domestic and foreign facilities manufacturing human or animal drugs regulated by CDER, CBER, or CVM, including combination-product manufacturers when CDER or CBER is the lead center. Key recommendations include structured response formatting, executive summaries, detailed remediation plans, risk assessments, and interim reporting requirements.
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