Expert Analysis

• 5 Open Questions About FDA's AI-Assisted Review Plans

  

  The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

• Bid Protest Spotlight: Jurisdiction, Price Range, Late-Is-Late

  

  In this month's bid protest roundup, Thomas Lee at MoFo examines three May decisions from the U.S. Court of Federal Claims examining the court’s jurisdiction to rescind an executive order, the impact of agency error in establishing a competitive price range and application of the late-is-late rule to an electronic filing.

• How Trump Administration's Antitrust Agenda Is Playing Out

  

  Under the current antitrust agency leadership, the latest course in merger enforcement, regulatory approach and key sectors shows a marked shift from Biden-era practices and includes a return to remedies and the commitment to remain focused on the bounds of U.S. law, say attorneys at Wilson Sonsini.

• Justices' Ruling Lowers Bar For Reverse Discrimination Suits

  

  The U.S. Supreme Court's unanimous opinion in Ames v. Ohio Department of Youth Services, lowering the evidentiary burden for plaintiffs bringing so-called reverse discrimination claims, may lead to more claims brought by majority group employees — and open the door to legal challenges to employer diversity, equity and inclusion initiatives, say attorneys at Ice Miller.

• Fed's Crypto Guidance Yank Could Drive Innovation

  

  The Federal Reserve Board's recent withdrawal of guidance letters brings regulatory consistency and broadens banks' ability to innovate in the crypto-asset space, but key distinctions remain between the Fed's policy on crypto liquidity and that of the other banking regulators, says Dan Hartman at Nutter.

• DOE Grant Recipients Facing Termination Have Legal Options

  

  Federal grant recipients whose awards have recently been rescinded by the U.S. Deparment of Energy have options for successfully challenging those terminations through litigation, say attorneys at Bracewell.

• Attacks On Judicial Independence Tend To Manifest In 3 Ways

  

  Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.

• Loophole To Budget Bill's AI Rule May Complicate Tech Regs

  

  An exception in the One Big Beautiful Bill Act that could allow state and local governments to develop ostensibly technology-neutral laws that nonetheless circumvent the bill’s ban on state artificial intelligence regulation could unintentionally create a more complex regulatory environment for technologies beyond AI, says Pooya Shoghi at Lee & Hayes.

• A Look At Texas Corp. Law Changes Aimed At Dethroning Del.

  

  Seeking to displace Delaware as the preferred locale for incorporation, Texas recently significantly amended its business code, including changes like codifying the business judgment rule, restricting books and records demands, and giving greater protections for officers and directors in interested transactions, say attorneys at Fenwick.

• Prior Art Ruling Highlights Importance Of Detailed Elaboration

  

  The U.S. Patent and Trademark Office's recent decision in Ecto World v. RAI Strategic Holdings shows that when there is a possibility for discretionary denial, and the examiner has potentially overlooked prior art, patent owners should elaborate on as many of the denial factors as possible, says Frank Bernstein at Squire Patton.

• Dissecting House And Senate's Differing No-Tax-On-Tips Bills

  

  Employers should understand how the House and Senate versions of no-tax-on-tips bills differ — including in the scope of related deductions and reporting requirements — to meet any new compliance obligations and communicate with their employees, say attorneys at Greenberg Traurig.

• OCC's Digital Embrace Delivers Risk, Opportunity For Banks

  

  As the Office of the Comptroller of the Currency continues to release and seek more information on banks' participation in the crypto-asset arena, institutions may see greater opportunity to pursue digital asset and custody services, but must simultaneously educate themselves on transformations occurring throughout the industry, says Kirstin Kanski at Spencer Fane.

• High Court Birthright Case Could Reshape Judicial Power

  

  Recent arguments before the U.S. Supreme Court in cases challenging President Donald Trump’s birthright citizenship executive order primarily focused on federal judges’ power to issue nationwide injunctions and suggest that the upcoming decision may fundamentally change how federal courts operate, says Mauni Jalali at Quinn Emanuel.

• Justices Hand Agencies Broad Discretion In NEPA Review

  

  By limiting the required scope of reviews under the National Environmental Policy Act, the U.S. Supreme Court's recent ruling in Seven County Infrastructure Coalition v. Eagle County could weaken the review process under NEPA, while also raising questions regarding the degree of deference afforded to agencies, say attorneys at Foley Hoag.

• Remediation Still Reigns Despite DOJ's White Collar Shake-Up

  

  Though the U.S. Department of Justice’s recently announced corporate enforcement policy changes adopt a softer tone acknowledging the risks of overregulation, the DOJ has not shifted its compliance and remediation expectations, which remain key to more favorable resolutions, say Jonny Frank, Michele Edwards and Chris Hoyle at StoneTurn.