DROPLETS
In-house counsel for small and mid-sized biopharmaceutical companies must monitor these reforms to help shape streamlined pathways that reduce barriers to US-based early-phase clinical research.
On June 22, 2026, HHS launched Operation TrialBlazer, a departmentwide initiative to reverse the years-long migration of early clinical trials to foreign jurisdictions including China and Australia, where Phase 1 trial start timelines are 40% shorter on average than in the US. As part of the push, FDA is piloting a risk-based expedited IND pathway for Phase 1 trials that cuts redundant administrative requirements, and has formally asked Congress to codify a permanent streamlined option. Biopharma in-house counsel should track public rulemaking, submit comments during open comment periods, and engage with HHS agencies to provide input on pathway implementation to reduce operational barriers to US-based early-stage research.
In-house employment and labor counsel for employers that use noncompete or confidentiality agreements with staff must review this guidance, as it confirms these standard terms do not constitute unfair labor practices under NLRB rules, lowering enforcement risk.
The NLRB General Counsel issued an advisory opinion addressing whether standard noncompete and confidentiality provisions in employee agreements constitute unfair labor practices (ULPs) under the National Labor Relations Act. The GC concluded these common contractual terms do not inherently violate NLRA protections for concerted employee activity, as they do not automatically restrict workers’ rights to discuss wages, working conditions, or organize. The guidance departs from prior NLRB efforts to scrutinize restrictive employment agreements as potential ULPs, providing employers with greater clarity for drafting and enforcing these provisions. In-house counsel should review existing agreement templates to ensure alignment with the GC’s outlined parameters, and update related onboarding and offboarding processes to reflect the clarified enforcement stance.
Drug manufacturers using distributed or foreign production must prepare for new FDA registration and listing requirements under a July 2026 proposed rule.
On July 13, 2026, FDA published a proposed rule overhauling drug establishment registration and drug listing requirements for distributed manufacturing (DM) sites and foreign establishments. The rule creates a dedicated registration and listing pathway for DM arrangements, where multiple sites contribute to a single finished drug product, and aligns foreign establishment obligations with current statutory requirements. Key impacts include new identification and listing obligations for each DM site, potential changes to U.S. agent designations, and updated expectations for cross-border supply chains. Manufacturers operating DM networks or relying on foreign production should evaluate site-level registration gaps, update listing data, and prepare comments before the comment period closes. Early compliance planning will be critical to avoid misbranding or registration lapses once the rule is finalized.
In-house counsel at FDIC-supervised banking institutions must evaluate the proposed first 30-year overhaul of confidential supervisory information rules, which would expand permissible non-public disclosures to a broader set of third parties without prior FDIC approval.
The FDIC has issued a proposed rule updating its Confidential Supervisory Information (CSI) disclosure framework for the first time since 1996, with public comments due August 31, 2026. If finalized, the rule would reorganize existing CSI regulations and eliminate prior approval requirements for disclosures of CSI to a wider range of recipients, including outside counsel, auditors, consultants, IT vendors, affiliate entities, and prospective merger partners, provided recipients sign confidentiality agreements and meet other specified conditions. In-house counsel at FDIC-regulated institutions should review the proposed rule now to evaluate needed updates to internal CSI handling and disclosure policies ahead of finalization.
In-house counsel overseeing remote hiring and workforce compliance must act, as DOJ enforcement exposes widespread corporate vulnerability to identity fraud schemes targeting remote IT roles.
On April 15, the U.S. Department of Justice sentenced two U.S. nationals in U.S. v. Wang (D. Mass.) for operating 'laptop farms' that enabled North Korean operatives to obtain remote IT jobs at more than 100 U.S. companies using stolen American identities. The scheme exploited weak identity verification processes in remote hiring pipelines to gain unauthorized access to corporate systems. Companies face risk of regulatory enforcement, data breaches, and sanctions violations if they fail to vet remote hires adequately. In-house counsel should collaborate with HR and security teams to implement robust multi-factor identity checks and regular audits of remote workforce credentials.
In-house employment counsel for employers using noncompete agreements must track evolving state-specific rules, as 2026 enforceability varies widely with no federal uniform standard, creating cross-jurisdictional compliance risk.
As of 2026, no federal noncompete ban has been enacted, so agreement enforceability is governed entirely by individual state law. A growing number of states have passed or are advancing reforms that restrict noncompete use, limit permissible scope, or ban the agreements for low-wage and other worker categories. In-house counsel should audit all existing noncompete agreements against the rules of every state where their workforce is located, update agreement templates to align with restrictive state requirements, and train HR teams on jurisdiction-specific rules to reduce unenforceability risk and avoid related litigation.
In-house counsel for consumer goods and services vendors operating in Pennsylvania must track this ruling, which narrows the scope of the state’s broad unfair trade practices catch-all provision for deceptive conduct claims.
The Pennsylvania Supreme Court held that a vendor’s silence does not constitute deceptive conduct under the state Unfair Trade Practices and Consumer Protection Law’s catch-all provision when the vendor has no legal duty to disclose the relevant information. The ruling resolves prior ambiguity around whether silence could trigger catch-all liability absent a duty to speak. In-house counsel for consumer goods and services vendors operating in Pennsylvania should review existing disclosure practices to confirm alignment with applicable legal duties to speak, and update relevant compliance training for customer-facing teams to reflect the narrowed scope of catch-all deceptive conduct liability.
In-house counsel for sports leagues, talent management firms and consumer brands with NIL-dependent assets must act because unregulated AI scraping of name, image and likeness content creates widespread, unaddressed infringement risks for valuable assets.
Existing U.S. trademark law can fill gaps in state-level name, image and likeness (NIL) right frameworks that have not kept pace with AI-driven content scraping. Claims for likelihood of confusion, false endorsement and trademark dilution may apply when AI tools generate or distribute content using protected NIL without authorization, even in states with limited NIL statutory protections. In-house counsel should audit NIL asset portfolios for registrable trademark elements, update licensing agreements to explicitly restrict AI use of NIL, and evaluate potential trademark claims against parties exploiting unlicensed NIL via AI.
Submarine cable SLTE owners and operators must meet new FCC licensing and national security requirements to retain operational authorization and avoid enforcement penalties.
On June 25, the FCC issued a Second Report and Order creating a mandatory blanket licensing regime for all entities that own or operate submarine line terminal equipment (SLTE) connected to U.S. cable landing points, paired with new national security reporting and certification mandates. The rules also establish an expedited review track for applicants meeting 10 specified national security standards, exempting them from standard Team Telecom review. Existing SLTE operators and submarine cable licensees must evaluate compliance with new filing requirements for modifications, transfers, renewals and ongoing operations, and update internal national security protocols to align with the FCC’s new requirements prior to the effective date.
In-house counsel for government contractors, federal grant recipients, and regulated industries with federal funding dependencies must track this process, as stalled FY2027 appropriations create operational and compliance uncertainty ahead of the September 30 fiscal year-end.
The article outlines stalled progress on FY2027 federal appropriations as Congress returns from recess with a compressed legislative timeline ahead of the September 30 fiscal year-end and 2026 midterm elections. House leadership has failed to advance multiple high-priority funding bills, including the National Defense Authorization Act and energy and water appropriations, amid internal partisan disputes, while Senate appropriators lack a bipartisan topline spending agreement and face reduced Republican membership following Senator Lindsey Graham’s death. In-house counsel for impacted entities should monitor developments closely, as delayed appropriations may trigger funding gaps, delayed contract awards, and adjusted compliance timelines for federally funded operations.
In-house counsel overseeing patent portfolios and parallel PTAB IPR and district court litigation must note this change, as it permits late Director Review requests for IPR institution decisions when co-pending litigation outcomes create materially changed case circumstances.
In a precedential sua sponte decision, USPTO Director Squires vacated three PTAB inter partes review (IPR) institution decisions nearly six months post-institution, after a co-pending district court found all challenged claims invalid under 35 U.S.C. § 101. The PTAB had previously denied a motion to terminate the IPR, citing no authority to end proceedings for discretionary reasons. The Director first extended the standard 14-day deadline to request Director Review of institution decisions to 30 days, aligning it with deadlines for other Director Review requests. He also established that “exceptional circumstances” — including co-pending claim dismissals, invalidity findings, or Sotera stipulation violations — allow further deadline extensions, provided trial has not meaningfully progressed. The § 101 invalidity finding qualified as an exceptional circumstance here, leading the Director to vacate the institution decisions and terminate the IPR.
In-house counsel for small and mid-sized biopharmaceutical companies must monitor these reforms to help shape streamlined pathways that reduce barriers to US-based early-phase clinical research.
On June 22, 2026, HHS launched Operation TrialBlazer, a departmentwide initiative to reverse the years-long migration of early clinical trials to foreign jurisdictions including China and Australia, where Phase 1 trial start timelines are 40% shorter on average than in the US. As part of the push, FDA is piloting a risk-based expedited IND pathway for Phase 1 trials that cuts redundant administrative requirements, and has formally asked Congress to codify a permanent streamlined option. Biopharma in-house counsel should track public rulemaking, submit comments during open comment periods, and engage with HHS agencies to provide input on pathway implementation to reduce operational barriers to US-based early-stage research.
In-house counsel at FDIC-supervised banking institutions must evaluate the proposed first 30-year overhaul of confidential supervisory information rules, which would expand permissible non-public disclosures to a broader set of third parties without prior FDIC approval.
The FDIC has issued a proposed rule updating its Confidential Supervisory Information (CSI) disclosure framework for the first time since 1996, with public comments due August 31, 2026. If finalized, the rule would reorganize existing CSI regulations and eliminate prior approval requirements for disclosures of CSI to a wider range of recipients, including outside counsel, auditors, consultants, IT vendors, affiliate entities, and prospective merger partners, provided recipients sign confidentiality agreements and meet other specified conditions. In-house counsel at FDIC-regulated institutions should review the proposed rule now to evaluate needed updates to internal CSI handling and disclosure policies ahead of finalization.
In-house counsel for consumer goods and services vendors operating in Pennsylvania must track this ruling, which narrows the scope of the state’s broad unfair trade practices catch-all provision for deceptive conduct claims.
The Pennsylvania Supreme Court held that a vendor’s silence does not constitute deceptive conduct under the state Unfair Trade Practices and Consumer Protection Law’s catch-all provision when the vendor has no legal duty to disclose the relevant information. The ruling resolves prior ambiguity around whether silence could trigger catch-all liability absent a duty to speak. In-house counsel for consumer goods and services vendors operating in Pennsylvania should review existing disclosure practices to confirm alignment with applicable legal duties to speak, and update relevant compliance training for customer-facing teams to reflect the narrowed scope of catch-all deceptive conduct liability.
In-house counsel overseeing remote hiring and workforce compliance must act, as DOJ enforcement exposes widespread corporate vulnerability to identity fraud schemes targeting remote IT roles.
On April 15, the U.S. Department of Justice sentenced two U.S. nationals in U.S. v. Wang (D. Mass.) for operating 'laptop farms' that enabled North Korean operatives to obtain remote IT jobs at more than 100 U.S. companies using stolen American identities. The scheme exploited weak identity verification processes in remote hiring pipelines to gain unauthorized access to corporate systems. Companies face risk of regulatory enforcement, data breaches, and sanctions violations if they fail to vet remote hires adequately. In-house counsel should collaborate with HR and security teams to implement robust multi-factor identity checks and regular audits of remote workforce credentials.
In-house employment and labor counsel for employers that use noncompete or confidentiality agreements with staff must review this guidance, as it confirms these standard terms do not constitute unfair labor practices under NLRB rules, lowering enforcement risk.
The NLRB General Counsel issued an advisory opinion addressing whether standard noncompete and confidentiality provisions in employee agreements constitute unfair labor practices (ULPs) under the National Labor Relations Act. The GC concluded these common contractual terms do not inherently violate NLRA protections for concerted employee activity, as they do not automatically restrict workers’ rights to discuss wages, working conditions, or organize. The guidance departs from prior NLRB efforts to scrutinize restrictive employment agreements as potential ULPs, providing employers with greater clarity for drafting and enforcing these provisions. In-house counsel should review existing agreement templates to ensure alignment with the GC’s outlined parameters, and update related onboarding and offboarding processes to reflect the clarified enforcement stance.
In-house employment counsel for employers using noncompete agreements must track evolving state-specific rules, as 2026 enforceability varies widely with no federal uniform standard, creating cross-jurisdictional compliance risk.
As of 2026, no federal noncompete ban has been enacted, so agreement enforceability is governed entirely by individual state law. A growing number of states have passed or are advancing reforms that restrict noncompete use, limit permissible scope, or ban the agreements for low-wage and other worker categories. In-house counsel should audit all existing noncompete agreements against the rules of every state where their workforce is located, update agreement templates to align with restrictive state requirements, and train HR teams on jurisdiction-specific rules to reduce unenforceability risk and avoid related litigation.
In-house counsel for small and mid-sized biopharmaceutical companies must monitor these reforms to help shape streamlined pathways that reduce barriers to US-based early-phase clinical research.
On June 22, 2026, HHS launched Operation TrialBlazer, a departmentwide initiative to reverse the years-long migration of early clinical trials to foreign jurisdictions including China and Australia, where Phase 1 trial start timelines are 40% shorter on average than in the US. As part of the push, FDA is piloting a risk-based expedited IND pathway for Phase 1 trials that cuts redundant administrative requirements, and has formally asked Congress to codify a permanent streamlined option. Biopharma in-house counsel should track public rulemaking, submit comments during open comment periods, and engage with HHS agencies to provide input on pathway implementation to reduce operational barriers to US-based early-stage research.
Drug manufacturers using distributed or foreign production must prepare for new FDA registration and listing requirements under a July 2026 proposed rule.
On July 13, 2026, FDA published a proposed rule overhauling drug establishment registration and drug listing requirements for distributed manufacturing (DM) sites and foreign establishments. The rule creates a dedicated registration and listing pathway for DM arrangements, where multiple sites contribute to a single finished drug product, and aligns foreign establishment obligations with current statutory requirements. Key impacts include new identification and listing obligations for each DM site, potential changes to U.S. agent designations, and updated expectations for cross-border supply chains. Manufacturers operating DM networks or relying on foreign production should evaluate site-level registration gaps, update listing data, and prepare comments before the comment period closes. Early compliance planning will be critical to avoid misbranding or registration lapses once the rule is finalized.
In-house counsel for government contractors, federal grant recipients, and regulated industries with federal funding dependencies must track this process, as stalled FY2027 appropriations create operational and compliance uncertainty ahead of the September 30 fiscal year-end.
The article outlines stalled progress on FY2027 federal appropriations as Congress returns from recess with a compressed legislative timeline ahead of the September 30 fiscal year-end and 2026 midterm elections. House leadership has failed to advance multiple high-priority funding bills, including the National Defense Authorization Act and energy and water appropriations, amid internal partisan disputes, while Senate appropriators lack a bipartisan topline spending agreement and face reduced Republican membership following Senator Lindsey Graham’s death. In-house counsel for impacted entities should monitor developments closely, as delayed appropriations may trigger funding gaps, delayed contract awards, and adjusted compliance timelines for federally funded operations.
In-house counsel overseeing patent portfolios and parallel PTAB IPR and district court litigation must note this change, as it permits late Director Review requests for IPR institution decisions when co-pending litigation outcomes create materially changed case circumstances.
In a precedential sua sponte decision, USPTO Director Squires vacated three PTAB inter partes review (IPR) institution decisions nearly six months post-institution, after a co-pending district court found all challenged claims invalid under 35 U.S.C. § 101. The PTAB had previously denied a motion to terminate the IPR, citing no authority to end proceedings for discretionary reasons. The Director first extended the standard 14-day deadline to request Director Review of institution decisions to 30 days, aligning it with deadlines for other Director Review requests. He also established that “exceptional circumstances” — including co-pending claim dismissals, invalidity findings, or Sotera stipulation violations — allow further deadline extensions, provided trial has not meaningfully progressed. The § 101 invalidity finding qualified as an exceptional circumstance here, leading the Director to vacate the institution decisions and terminate the IPR.
In-house counsel for sports leagues, talent management firms and consumer brands with NIL-dependent assets must act because unregulated AI scraping of name, image and likeness content creates widespread, unaddressed infringement risks for valuable assets.
Existing U.S. trademark law can fill gaps in state-level name, image and likeness (NIL) right frameworks that have not kept pace with AI-driven content scraping. Claims for likelihood of confusion, false endorsement and trademark dilution may apply when AI tools generate or distribute content using protected NIL without authorization, even in states with limited NIL statutory protections. In-house counsel should audit NIL asset portfolios for registrable trademark elements, update licensing agreements to explicitly restrict AI use of NIL, and evaluate potential trademark claims against parties exploiting unlicensed NIL via AI.
Submarine cable SLTE owners and operators must meet new FCC licensing and national security requirements to retain operational authorization and avoid enforcement penalties.
On June 25, the FCC issued a Second Report and Order creating a mandatory blanket licensing regime for all entities that own or operate submarine line terminal equipment (SLTE) connected to U.S. cable landing points, paired with new national security reporting and certification mandates. The rules also establish an expedited review track for applicants meeting 10 specified national security standards, exempting them from standard Team Telecom review. Existing SLTE operators and submarine cable licensees must evaluate compliance with new filing requirements for modifications, transfers, renewals and ongoing operations, and update internal national security protocols to align with the FCC’s new requirements prior to the effective date.