Expert Analysis

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• What FINRA Enforcement Changes Mean For Investigations

  

  It is essential for in-house counsel and compliance officers to familiarize themselves with the Financial Industry Regulatory Authority's recently announced changes to its enforcement program, which offer both clearer visibility into FINRA's expectations and a valuable opportunity to strengthen regulatory readiness, say attorneys at Eversheds Sutherland.

• One Idea To Fix The SEC's Risk Factor Disclosure Rules

  

  U.S. Securities and Exchange Commission Chairman Paul Atkins recently invited the industry to suggest ways to reform the current risk factor disclosure framework, and amending Rule 10b-5 is one potential option to consider, say attorneys at A&O Shearman.

• Navigating Venezuelan Oil And Gas Sanctions Rollbacks

  

  The U.S. Department of the Treasury's Office of Foreign Assets Control has issued a series of general licenses representing the broadest easing of Venezuela-related sanctions in years, and creating significant new opportunities — but only for entities prepared to meet the rigorous conditions attached to OFAC's phased sanctions relief, say attorneys at Winston & Strawn.

• 7 Employer Tips For Handling Calif. Privacy Risk Assessments

  

  Recent changes to the California Consumer Privacy Act require certain employers to complete detailed risk assessments before handling workforce data in many routine ways, so employers should assess whether previous risk assessments can be reused or combined, assemble a team, and create a plan of action, among other steps, say attorneys at Littler.

• Breaking Down State Legislative Efforts In Telecom Security

  

  As the federal government has strengthened national security safeguards for the telecommunications ecosystem, states have also asserted a role in telecom security, with variations among these regimes risking regulatory fragmentation and complicating compliance strategies, say attorneys at Hogan Lovells.

• Agentic AI Use May Trigger Existing Consumer Finance Laws

  

  As artificial intelligence agents interact more and more with payment systems, financial institutions should be cognizant of how existing consumer protection laws like the Equal Credit Opportunity Act apply when transactions are executed by automated systems rather than individuals, noting authorization and liability gaps, say attorneys at Sheppard.

• SEC Guidance Further Solidifies Status Of Tokenized Assets

  

  The U.S. Securities and Exchange Commission recently released a statement that tokenized securities are securities governed by traditional securities laws, representing continued regulatory clarity and the development of expanded technical standards and risk management guidelines that can only improve the long-term viability of financial markets, say attorneys at Barnes & Thornburg.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.

• What's Next For The Advanced Air Mobility Sector

  

  The U.S. Department of Transportation’s recent selection of electric vertical takeoff and landing pilot program participants marks a transition from aspirational policy to accountable implementation, and regulatory strategy should be at the center of business planning across the advanced air mobility ecosystem, say attorneys at Morgan Lewis.

• Emissions Permits May Not Override Pollution Exclusions

  

  Two recent coverage rulings from the Illinois Supreme Court and the Third Circuit suggest a trend among appellate courts to deny coverage under pollution exclusions, even when the emissions happened pursuant to a government permit, say attorneys at Simpson Thacher.

• 5 Tips For Navigating Your Firm's All-Attorney Summit

  Excerpt from Practical Guidance

  

  Law firm retreats should be approached strategically, as they present valuable opportunities to advance both the firm's objectives and attorneys' professional development through meaningful participation, building and strengthening internal relationships, and proactive follow-up, says James Argionis at Cozen O’Connor.

• CFTC's No-Action Relief Fuels Energy Market Competition

  

  The U.S. Commodity Futures Trading Commission recently launched a pilot program aimed at expanding access to energy markets, reflecting a shift toward supporting robust derivatives markets that balance regulatory safeguards with the needs of commodity end users, say attorneys at Moore & Van Allen.

• New NLRB GC Likely To Prioritize Efficiency Over Policy Shifts

  

  After the National Labor Relations Board operated without a quorum for nearly a year, general counsel Crystal Carey's early memoranda reflect a shift away from sweeping policy changes and toward clearing the case backlog, creating an environment that rewards employers' preparation and efficiency over prolonged litigation, says Michael Passarella at Olshan Frome.