Expert Analysis

• 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  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence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.

• 4chan's US Lawsuit May Affect UK Online Safety Law Reach

  

  4chan and Kiwi Farms’ pending case against the Office of Communications in a D.C. federal court, arguing that their constitutional rights have been violated, could have far-reaching implications for the extraterritorial enforcement of the U.K. Online Safety Act and other laws if successful, say lawyers at Taylor Wessing.

• 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.

• Ill. State Farm Suit Tests State Insurance Data Demand Limits

  

  The Illinois Department of Insurance's recently filed suit against State Farm, seeking nationwide data on its homeowners insurance, raises important issues as to the breadth, and possible overreach, of a state's regulatory authority, says Stephanie Pierce at Kutak Rock.

• How New FinCEN FAQs Simplify Suspicious Activity Reporting

  

  New guidance from the Financial Crimes Enforcement Network and federal banking agencies that gives financial institutions more flexibility in meeting suspicious activity reporting obligations indicates the administration is following through on its promise to streamline the U.S. anti-money laundering regime, say attorneys at Davis Polk.

• What Shutdown's End Means For Worker Safety Enforcement

  

  The Occupational Safety and Health Administration and Mine Safety and Health Administration may emerge from the government shutdown struggling to juggle complaint backlogs, litigation delays and newly enacted policies with a reduced and demoralized workforce, so employers should stay alert, say attorneys at Conn Maciel.

• SEC's Dual Share Class Approval Signals New Era For ETFs

  

  The U.S. Securities and Exchange Commission's recent approval of the dual share class structure marks a landmark moment for the U.S. fund industry, opening the door for asset managers to benefit from combining mutual fund and exchange-traded fund share classes under a single portfolio, say Ilan Guedj at Bates White and Brian Henderson at George Washington University.

• Calif. Species Protections Will Increase Compliance Burdens

  

  California's recently enacted A.B. 1319 automatically protects species when the federal government rolls back its own protections — which could mean an onslaught of state-level compliance mandates for the regulated community that come with no advance notice or public hearings, says attorney David Smith.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• Assessing The SEC's Changing Approach To NFT Regulation

  

  Early U.S. Securities and Exchange Commission actions on nonfungible tokens pushed for broad regulation, but subsequent court decisions — including a recent California federal court ruling in Adonis Real v. Yuga Labs — and SEC commissioners' statements have narrowed the regulatory focus toward a more fact-specific approach, say attorneys at Wilson Elser.

• Comey Case Highlights Complex Speedy Trial Rights Calculus

  

  Former FBI Director James Comey’s decision to waive his Speedy Trial Act rights in the false statement prosecution against him serves as a reminder that the benefits of invoking these rights are usually outweighed by the risks of inadequate preparation, but it can be an effective strategy in the right case, says Sara Kropf at Kropf Moseley.

• Breaking Down Article 12 Of The Uniform Commercial Code

  

  Thirty-two states and the District of Columbia have enacted Article 12 of the Uniform Commercial Code, providing the alternative to perfection by control of assets like cryptocurrency and nonfungible tokens, but before accepting these assets as collateral, lenders and creditors should consider how to best maintain priority, say attorneys at Miller Nash.

• Why Foreign Cos. Should Prep For Increased SEC Oversight

  

  With the recent trading suspensions of 10 foreign-based issuers listed on the Nasdaq, an enforcement action against a U.K. security-based swap dealer and the announcement of a cross-border task force, it's clear that the U.S. Securities and Exchange Commission will expand oversight on foreign companies participating in the U.S. capital markets, says Tejal Shah at Cooley.

• How Litigating Antitrust Fix Helped GTCR Prevail In Court

  

  An Illinois federal judge's recent denial of the Federal Trade Commission's injunction request in the GTCR acquisition of Surmodics joins a developing series of cases in which deal parties have prevailed against government antitrust challenges by proposing a post-complaint fix and litigating the as-amended deal, say attorneys at Paul Weiss.