Expert Analysis

• Key Takeaways From FDA Final Rule On Lab-Developed Tests

  

  Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

• Assessing HHS' Stance On Rare Disease Patient Assistance

  

  The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

• 7 Effects Of DOL Retirement Asset Manager Exemption Rule

  

  The recent U.S. Department of Labor amendment to the retirement asset manager exemption delivers several key practical impacts, including the need for managers, as opposed to funds, to register with the DOL, say attorneys at Ropes & Gray.

• Opinion

  Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

  

  The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

• 4 Sectors Will Likely Bear Initial Brunt Of FTC 'Junk Fees' Rule

  

  If the Federal Trade Commission adopts its comprehensive proposed rule to ban unfair or deceptive fees across the U.S. economy, many businesses — including those in the lodging, event ticketing, dining and transportation sectors — will need to reexamine the way they market and price their products and services, say attorneys at Skadden.

• Liquidity Risk Management Tops NCUA Exam Priorities

  

  As credit unions map their regulatory initiatives and audit plans, they should look to the National Credit Union Administration’s annual supervisory priorities, which include five important examination areas, including liquidity management and interest rate risk, say Juan Arciniegas and Judy Chen at Chapman and Cutler.

• Protecting IP May Be Tricky Without Noncompetes

  

  Contrary to the Federal Trade Commission's view, trade secret law cannot replace noncompetes' protection of proprietary information because intellectual property includes far more than just trade secrets, so businesses need to closely examine their IP protection options, say Aimee Fagan and Ching-Lee Fukuda at Sidley.

• Regulating Resurrected Species Under The ESA

  

  As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.

• 8 Legal Issues Influencing Investors In The Creator Economy

  

  The rapidly expanding digital creator economy — funding for which more than doubled in the U.S. in the first quarter — comes with its own set of unique legal issues investors must carefully consider before diving in, say Louis Lehot and Alan Pate at Foley & Lardner.

• Action Steps To Address New Restrictions On Outbound Data

  

  Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.

• E-Discovery Quarterly: Recent Rulings On Text Message Data

  

  Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

• CFPB Reality Check: Video Game Cash Is Still Money

  

  The Consumer Financial Protection Bureau's recent report examining payments within online video games indicates that financial services offered within the game marketplace are quickly evolving to the point where they are indistinguishable from traditional financial services subject to regulation, say attorneys at Sheppard Mullin.

• What CRA Deadline Means For Biden Admin. Rulemaking

  

  With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

• 5 Takeaways From FDA's Biosimilars Promotion Guidance

  

  New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

• The Legal Issues Raised In Minn. Rate Exportation Opt-Out Bill

  

  A recent Minnesota House bill would amend state law by opting out of the federal interest rate preemption and introduce several legal gray areas if passed, including issues regarding loan location, rates on credit card loans and values of state charters, says Karen Grandstrand at Fredrikson & Byron.