On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and
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CFPB Opens Public Probe on Closing Fees
On May 30, the CFPB announced that it was probing mortgage closing costs as part of its continued focus on so-called junk fees. The Bureau’s request for information seeks input from the public on “the impact closing costs have on borrowers…
FHA’s Releases 12-Hour Cyber Incident Notification Rule
On May 23, the U.S. Department of Housing and Urban Development (HUD) announced that Federal Housing Administration-approved Mortgagees are subject to a heightened cybersecurity incident reporting regime. The new requirement, which amends the Single Family Housing Policy Handbook 4000.1, requires…
South Carolina Enacts Earned Wages Access Law
On May 21, less than a month after Kansas, South Carolina has become the fifth state to enact comprehensive earned wages access (EWA) legislation, which is set to take effect on November 21, 2024.…
CFPB Files Motion for Summary Judgment on HDMA Enforcement Action
On May 16, the CFPB filed a motion for summary judgement in the U.S. District Court in the Southern District of Florida seeking a $20 million civil penalty against a California-based mortgage provider for allegedly submitting inaccurate government mortgage loan…
Supreme Court Rules That Judges – Not Arbitrators – Must Resolve Disputes Where Various Agreements May Govern a Particular Dispute and Those Agreements Conflict on the Forum for Deciding Arbitrability
In 23-3 Coinbase, Inc. v. Suski (05/23/2024) (supremecourt.gov) (May 23, 2024), the U.S. Supreme Court once again delved into the frequently litigated arena of arbitration agreements. Specifically, the Court considered whether the Federal Arbitration Act (“FAA”) empowers courts or arbitrators to…
Congress Seeks to Extend COVID-19 Telehealth Flexibilities Through 2026 and Expand Reimbursement
On May 16, 2024, the Subcommittee on Health of the House Committee on Energy and Commerce (the “Subcommittee”) announced that it advanced the Telehealth Modernization Act of 2024 (H.R. 7623) as amended (the “Bill”) during a markup session. The Bill…
E(U)xterritoriality of EU Sanctions: The No Russia Clause
The EU is going extraterritorial, and it is doing so through private contract. It is a pretty neat trick.…
Treasury Department Proposes to Sharpen the Teeth of CFIUS Enforcement
Key Takeaways: The Treasury Department is seeking to equip CFIUS with greater enforcement and oversight authority. These new powers include the ability to request more information from transaction parties and also to assess more significant penalties—in some cases, potentially greater than the…
Walking the Tightrope: EU’s Sanctions Enforcement Directive Puts Violators on Notice
In a bold move to tighten its sanctions enforcement, the EU rolled out Directive 2024/1226, establishing minimum rules for defining criminal offenses and penalties related to the violation of EU sanctions. Effective May 19, the Directive mandates Member States…