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Expert Analysis

• What's New In FDA's Latest Cell And Gene Therapy Guidance

  

  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.

• CFIUS Trends May Shift Under 'America First' Policy

  

  The arrival of the Committee on Foreign Investment in the United States' latest annual report suggests that the Trump administration's "America First" policy will have a measurable effect on foreign investment, including improved trendlines for investments from allied sources and increasingly negative trendlines for those from foreign adversary sources, say attorneys at Debevoise.

• How Gov't May Use FARA To Target 'Domestic Terrorism'

  

  After the Trump administration’s recent memo directing law enforcement to use the Foreign Agents Registration Act to prosecute domestic terrorism, nonprofit organizations receiving funding from foreign sources must assess their registration obligations under the statute, say attorneys at Pillsbury.

• What's Changing For Cos. In New Calif. Hazardous Waste Plan

  

  While the latest hazardous waste management plan from California's Department of Toxic Substances Control still awaits final approval, companies can begin aligning internal systems now with the plan's new requirements for environmental justice, waste and disposal reduction, waste criteria, and capacity planning, says Thierry Montoya at Frost Brown.

• What CFTC Push For Tokenized Collateral Means For Crypto

  

  The Commodity Futures Trading Commission's recent request for comment on the use of tokenized products as collateral in derivatives markets signals that it is expanding the scope and form of eligible collateral, and could broaden the potential use cases for crypto-assets held in tokenized form, say attorneys at Dechert.

• H-1B Fee Guidance Is Helpful But Notable Uncertainty Persists

  

  Recent guidance narrowing the scope of the $100,000 entry fee for H-1B visas will allow employers to plan for the hiring season, but a lack of detail about the mechanics of cross-agency payment verification, fee exemptions and other practical matters still need to be addressed, say attorneys at Klasko Immigration Law Partners.

• Navigating EPA Compliance As Gov't Shutdown Continues

  

  As the federal government shutdown drags on, industries regulated by the U.S. Environmental Protection Agency can expect application and permitting delays, limited guidance from EPA personnel regarding compliance matters, and stalled court proceedings — but there are strategies that can help companies deal with these problems, says Lauren Behan at Goldberg Segalla.

• State Of Insurance: Q3 Notes From Pennsylvania

  

  Todd Leon at Marshall Dennehey discusses three notable Pennsylvania auto insurance developments from the third quarter, including the Third Circuit weighing in on actual cash value, a state appellate court opining on the regular use exclusion and state legislators introducing a bill to increase property damage minimums.

• How Calif. Zoning Bill Is Addressing The Housing Crisis

  

  The recently signed S.B. 79 represents a significant step in California's ongoing efforts to address the housing crisis by upzoning properties near qualifying transit stations in urban counties, but counsel advising on S.B. 79 will have to carefully parse eligibility and compliance with the bill and related statutes, says Jennifer Lynch at Manatt.

• Series

  Practicing Stoicism Makes Me A Better Lawyer

  

  Practicing Stoicism, by applying reason to ignore my emotions and govern my decisions, has enabled me to approach challenging situations in a structured way, ultimately providing advice singularly devoted to a client's interest, says John Baranello at Moses & Singer.

• How Courts Treat Nonservice Clauses For Financial Advisers

  

  Financial advisers considering a job change should carefully consider recent cases that examine controlling state law for nonservice and nonacceptance provisions to prepare for potential legal challenges from former firms, says Andrew Shedlock at Kutak Rock.

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  The Biz Court Digest: Texas, One Year In

  

  A year after the Texas Business Court's first decision, it's clear that Texas didn't just copy Delaware and instead built something uniquely its own, combining specialization with constitutional accountability and creating a model that looks forward without losing touch with the state's democratic and statutory roots, says Chris Bankler at Jackson Walker.

• UPEPA Case Tackles Fans' Interactions With Public Figures

  

  A New Jersey Superior Court's granting of an order to show cause seeking dismissal against New York Jets cornerback Ahmad "Sauce" Gardner may carry broad implications for the state's Uniform Public Expression Protection Act, say attorneys at Gordon Rees.

• AG Watch: Illinois A Key Player In State-Level Enforcement

  

  Illinois Attorney General Kwame Raoul has systematically strengthened his office to fill federal enforcement gaps, oppose Trump administration mandates and advance state policy objectives, particularly by aggressively pursuing labor-related issues, say attorneys at Troutman.

• Border Czar Bribery Probe Spotlights 'Public Official' Scope

  

  Reports that border czar Tom Homan allegedly accepted cash from a federal agent prior to his appointment raise important questions for government contractors about when a private citizen can be prosecuted as a public official under federal bribery laws, say Gregory Rosen at Rogers Joseph and Jason Manning at Levy Firestone.