Expert Analysis

• FDA Guidance May Move Goalposts For Form 483 Responses

  

  New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about the agency's timelines and expectations, say attorneys at Cooley.

• Understanding The SEC's Consequential Crypto Guidance

  

  The U.S. Securities and Exchange Commission's recent interpretive release — its most comprehensive statement ever on the application of the federal securities laws to crypto-assets — reimagines the Howey test to resolve long-standing questions over what is a security, but leaves many issues unresolved, say attorneys at Cahill.

• Ohio Case Reflects States' Aggressive Criminal Antitrust Turn

  

  The Ohio Attorney General's Office’s recent bid-rigging indictment of an online auctioneer is the latest signal that states, through attorneys general pursuing more kickback cases and legislators expanding the reach of antitrust laws, are shedding their historical reluctance to wield their criminal antitrust enforcement powers, say attorneys at Arnold & Porter.

• Justices' Geofence Ruling May Test 4th Amendment's Future

  

  When the U.S. Supreme Court decides in Chatrie v. U.S. whether law enforcement may use geofence warrants to compel Google to disclose location history data, the ruling is likely to become an important statement about the future of Fourth Amendment law in data-driven investigations, says Duncan Levin at Levin & Associates.

• Series

  NY Banking Brief: All The Notable Legal Updates In Q1

  

  In the first quarter of 2026, New York's banking developments were headlined by initiatives to expand oversight of financial institutions and strengthen consumer protection laws, including a new framework for buy now, pay later lenders, a sweeping debt collection rule and a revised corporate self-disclosure program for financial crimes, say attorneys at Proskauer.

• Seeking A Policy Fix As Merger Reporting Fight Continues

  

  A recently announced request by the Federal Trade Commission and U.S. Department of Justice for public comment on the Hart-Scott-Rodino premerger reporting requirements, as litigation challenging the commission's updated requirements continues, suggests the government's willingness to address how best to support modern merger enforcement without unduly burdening filing parties, say attorneys at Baker Botts.

• What New Fla. Citizens Bill Means For Surplus Lines Insurers

  

  A Florida bill recently passed by the Legislature as part of a continued effort to depopulate Citizens Property Insurance, the state's insurer of last resort, creates an additional pathway for commercial policies to be written by surplus lines insurers, but also presents concerns of unnecessary regulation, say attorneys at Troutman.

• What Voluntary Calif. Carbon Reports Show About Compliance

  

  While the enforcement of California's S.B. 261 is currently paused due to a Ninth Circuit injunction, more than 130 companies have nonetheless chosen to voluntarily publish climate-related financial risk disclosures, providing a useful snapshot of how the market is interpreting the law's requirements in practice, say attorneys at DLA Piper.

• PTAB Memo Recenters Discretion On US Manufacturing

  

  Read alongside recent Federal Circuit decisions, U.S. Patent and Trademark Office Director John Squires' memo on patent denial considerations emphasizes domestic manufacturing in a way that the International Trade Commission does not require, says Brandon Theiss at Volpe Koenig.

• Why MDLs Slow Down — And How To Speed Them Up

  

  Multidistrict litigation has become central to mass tort practice, but as MDLs grow in size and complexity, so do delays and costs — so tools like the new federal rule governing MDLs, targeted use of special masters and strategically deployed Lone Pine orders are more essential than ever, say attorneys at Ice Miller.

• What A Court Doc Audit Reveals About Erroneous Filings

  

  My audit of 1,522 court documents from last month found that over 95% contained at least one verifiable error, with fewer than 1% showing clear indicators of artificial intelligence use — highlighting above all else that lawyers may want to focus most on strengthening their review processes, says Elliott Ash at ETH Zurich.

• Regulators' Basel Pitch May Bring Banks Capital Relief

  

  The prudential banking agencies' new proposals to implement the so-called Basel III endgame rules — which would modify the approach to risk-based capital, among other notable changes — represent a fundamental directional shift in bank capital requirements aimed at increasing lending capacity, says Chen Xu at Debevoise.

• How SEC And CFTC Are Attempting To End Their 'Turf War'

  

  Through coordinated examinations and a shared aim to end duplicative regulation, the U.S. Securities and Exchange Commission and the U.S. Commodity Futures Trading Commission's recent memorandum of understanding could represent a significant shift in the regulatory landscape for market participants subject to the jurisdiction of both agencies, say attorneys at Jenner.

• FTC Focus: Growing Emphasis On Competition In AI

  

  The Federal Trade Commission's leadership has continued to highlight that competitive risks in artificial intelligence markets may arise at multiple levels simultaneously, considering not only who controls the resources necessary to build AI systems, but also how those systems function and yield outputs, say attorneys at Proskauer.

• What's Missing From Latest Gov't Claims Against Harvard

  

  The most interesting thing about the Trump administration’s recent civil rights enforcement efforts targeting Harvard University is its decision not to assert violations of the False Claims Act when given the opportunity, despite signals that its enforcement efforts will include use of the federal FCA, say attorneys at Bass Berry.