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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  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by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.

• 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.

• Risk Mitigation For Psychedelic Use In Reproductive Health

  

  With the rising use of psychedelics among women of reproductive age and the absence of clear professional guidelines regarding risk labeling, healthcare providers and facilitators should adopt proactive, evidence-based approaches to mitigate malpractice liability risks, say Kimberly Chew at Husch Blackwell and Sara Shoar at the University of Southern California.

• Justices' LabCorp Punt Leaves Deeper Class Cert. Circuit Split

  

  In its ruling in LabCorp v. Davis, the U.S. Supreme Court left unresolved a standing-related class certification issue that has plagued class action jurisprudence for years — and subsequent conflicting decisions among federal circuit courts have left district courts and litigants struggling with conflicting and uncertain standards, say attorneys at Cozen O'Connor.

• 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.

• Adapting To Enforcement Focus On Wound Care Fraud

  

  As federal agencies target wound care industry fraud as a top enforcement priority, attorneys advising industry stakeholders should evaluate business relationships for Anti-Kickback Statute violations, emphasize appropriate product use and documentation, and use internal data analytics to monitor billing patterns, say David Tarras at Tarras Defense and Jay McCormack at Verrill Dana.

• Series

  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.

• AI Product Safety Insights May Expand Foreseeability

  

  Product liability law has long held that companies are responsible for risks they knew about or should have known about — and with AI systems now able to assess and predict hazards during the design process, companies should expect that courts will likely treat such hazards as foreseeable, says Donald Fountain at Clark Fountain.

• 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.

• Series

  Law School's Missed Lessons: Educating Your Community

  

  Nearly two decades prosecuting scammers and elder fraud taught me that proactively educating the public about the risks they face and the rights they possess is essential to building trust within our communities, empowering otherwise vulnerable citizens and preventing wrongdoers from gaining a foothold, says Roger Handberg at GrayRobinson.

• Organ Transplant System Reforms Mark Regulatory Overhaul

  

  Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.

• Federal Grantees May Soon Face More Limitations On Speech

  

  If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.

• 5 Crisis Lawyering Skills For An Age Of Uncertainty

  

  As attorneys increasingly face unprecedented and pervasive situations — from prosecutions of law enforcement officials to executive orders targeting law firms — they must develop several essential competencies of effective crisis lawyering, says Ray Brescia at Albany Law School.

• Anticipating FTC's Shift On Unfair Competition Enforcement

  

  As the Federal Trade Commission signals that it will continue to challenge unfair or deceptive acts and practices under Section 5 of the FTC Act, but with higher evidentiary standards, attorneys counseling healthcare, technology, energy or pharmaceuticals clients should note several practice tips, says Thomas Stratmann at George Mason University.

• Opinion

  It's Time For The Judiciary To Fix Its Cybersecurity Problem

  

  After recent reports that hackers have once again infiltrated federal courts’ electronic case management systems, the judiciary should strengthen its cybersecurity practices in line with executive branch standards, outlining clear roles and responsibilities for execution, says Ilona Cohen at HackerOne.