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FDA Issues Draft Guidance On Container Closure Systems For Human Drugs And Biological Products
The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.
United States Healthcare
SJ
Steptoe LLP
Article
Travel On Advance Parole May Now Trigger Immigration Bars
A recent Board of Immigration Appeals decision fundamentally changes how advance parole travel affects immigration status, potentially triggering a 10-year bar for DACA recipients, TPS holders, and green card applicants with prior unlawful presence. This ruling overturns 14 years of precedent and creates significant new risks for workers and employers who rely on advance parole for international travel.
United States Immigration
K
Klasko
Article
Mind The Gap: When Your Retirement Plan Document, Plan Operations, And Participant Communications Do Not Match
Plan sponsors face a critical December 31, 2026 deadline to adopt amendments reflecting SECURE 1.0, SECURE 2.0, and CARES Act provisions in their qualified retirement plan documents. Many plans have been operating under these laws for years without updated plan language, creating a gap between plan operations, participant communications, and formal documentation. This comprehensive guide identifies which amendments must be adopted, provides a detailed checklist of provisions requiring documentation, and out
United States Employment
FL
Foley & Lardner
Article
Fort Monmouth Redevelopment and the Transformation of Monmouth County Real Estate
Netflix's $1 billion Fort Monmouth studio investment is transforming Monmouth County's real estate landscape, creating unprecedented opportunities across industrial, hospitality, and commercial sectors. With 12 soundstages under construction and 86% of the former military base now under contract, sophisticated investors are repositioning their strategies to capture value in adjacent submarkets before the 2027 opening.
United States Real Estate
SH
Scarinci Hollenbeck LLC
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