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Expert Analysis

• 3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

  

  The U.S. Food and Drug Administration recently published draft guidance documents that sketch the clearest picture yet of the evolving regulatory framework for cell and gene therapies, reflecting an agency that is increasingly comfortable with flexible, science-driven approaches that extend beyond clinical trial models, say attorneys at MoFo.

• Wells Process Reforms Serve SEC Chair's Transparency Goals

  

  Enforcement policy changes U.S. Securities and Exchange Commission Chairman Paul Atkins recently set forth will help fulfill his stated goal of making Division of Enforcement investigations more fair and transparent by changing the Wells process to provide recipients earlier consultations with SEC staff, greater evidence access and more time to file responses, say attorneys at Dechert.

• The Ins And Outs Of Decentralized Digital Asset Exchanges

  

  As decentralized digital asset exchanges lack intermediaries, and so remain susceptible to fraud and market manipulation, ​​​​​​​an understanding of their design is crucial to help market participants avoid fraudulent practices such as liquidity rug pulls, says Swati Kanoria at Charles River.

• Contradictory Rulings Show Complexity Of Swaps Regulation

  

  Recent divergent rulings, including two by the same Nevada judge, on whether the Commodity Exchange Act preempts state gambling laws when applied to event contracts traded on U.S. Commodity Futures Trading Commission-regulated markets illustrate the uncertainty regarding the legality of prediction markets, say attorneys at Akin.

• How New Law Transforms Large-Load Power Projects In Texas

  

  S.B. 6 — the new Texas law that revises state regulations for large electrical loads and related behind-the-meter projects — introduces higher up-front costs for developers and more flexible operating models for large-load customers, but should provide the certainty needed for greater investment in generation, say attorneys at Sidley.

• How Cos. Should Prepare For Prop 65 Listing Of Bisphenols

  

  California regulators are moving toward classifying all p,p'-bisphenol chemicals as causing reproductive toxicity under Proposition 65, which could require warning notices for a vast range of consumer and industrial products, and open the floodgates to private litigation — so companies should proactively review their suppy chains, says Gregory Berlin at Alston & Bird.

• Rule Amendments Pave Path For A Privilege Claim 'Offensive'

  

  Litigators should consider leveraging forthcoming amendments to the Federal Rules of Civil Procedure, which will require early negotiations of privilege-related discovery claims, by taking an offensive posture toward privilege logs at the outset of discovery, says David Ben-Meir at Ben-Meir Law.

• Series

  My Miniature Livestock Farm Makes Me A Better Lawyer

  

  Raising miniature livestock on my farm, where I am fully present with the animals, is an almost meditative time that allows me to return to work invigorated, ready to juggle numerous responsibilities and motivated to tackle hard issues in new ways, says Ted Kobus at BakerHostetler.

• When Mortgage Data Can't Prove Discriminatory Lending

  

  As plaintiffs continue to use Home Mortgage Disclosure Act data as grounds for class actions, attorneys must consider the limits of a statistics-only approach and the need for manual loan file review to confirm indications of potential discriminatory lending, say Abe Chernin, Shane Oka and Kevin Oswald at Cornerstone Research.

• NLRB Memo Shifts Tone On Defenses Against Union 'Salting'

  

  The current Starbucks strike demonstrates the potential effects of salting, in which applicants seek employment in order to organize a union, and recent guidance from the National Labor Relations Board suggests that previously rejected employer defenses may now gain traction, says Daniel Johns at Cozen O'Connor.

• Evaluating Nasdaq Tokenization Rule's Potential Impact

  

  Nasdaq's recently proposed rule would enable settlement of tokenized equity securities and exchange-traded products using blockchain technology, which could lead to dramatic improvements in market efficiency, settlement speed and market access, but prudent skepticism about timelines and implementation capabilities is warranted, says James Brady at Katten.

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Preparing For Treasury's Small Biz Certification Audits

  

  To prepare for the U.S. Department of the Treasury’s recently announced audit of small and disadvantaged government contractors, companies should assess the records that supported their prior certifications and confirm their current eligibility, particularly if they share ownership with another entity or were recently acquired, say attorneys at Morgan Lewis.

• Navigating Sanctions Against Colombia's Head Of State

  

  To limit their exposure from recent sanctions that prohibit dealings with Colombia’s president and specific officials, it is critical that U.S. companies gain a fulsome understanding of potential touchpoints, establish controls to avoid engagement and, if necessary, seek U.S. government approval, say attorneys at Perkins Coie.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.