FinCEN has extended the now (again) mandatory BOIR filing deadline by 30 calendar days to March 21, 2025. The only exception to the mandatory filing requirement are the Plaintiffs in the National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala) action.
Construction
Joint Petition for Dissolution – A Solution for those seeking a Conscious Uncoupling
In California, the definition of “domestic violence” extends far beyond the traditional notions of physical and emotional harm. The definition of what constitutes “abuse” and “domestic violence” is no longer limited to acts inflicting physical injury.
Artificial Intelligence for Drug & Biological Products – Credibility of AI Models for Context of Use – The “Model Risk” Paradigm
The FDA has recently issued draft guidance (non-binding recommendations) for drug and biological product sponsors and computer programmers regarding the use of Machine Learning (ML) and artificial intelligence (AI) to support regulatory decision-making about the safety, effectiveness, or quality of drugs.
Breaking The Hidden Chains: Financial Abuse as Domestic Violence in California
In California, the definition of “domestic violence” extends far beyond the traditional notions of physical and emotional harm. The definition of what constitutes “abuse” and “domestic violence” is no longer limited to acts inflicting physical injury.
Beneficial Ownership Reporting – To File or Not to File?
Considering conflicting rulings, businesses remain understandably confused about whether to file their mandated Beneficial Ownership Reports with FinCen. As of this writing, the answer remains that businesses may file but are not (yet) required to do so.
FDA Issues Draft Guidance for Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics
On December 5, 2024, the FDA’s Center for Drug Evaluation and Research (CDER), along with the Center for Biologics Evaluation and Research (CBER) and the Oncology Center of Excellence (OCE) issued draft guidance concerning expedited programs for serious conditions.
9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs
In United States v. California Stem Cell Treatment Center, Inc. , the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the Food, Drug, and Cosmetic Act (FDCA).
Iconic Photograph Lands Hall Of Famer Barry Sanders In Court
Professional sports photographer, Allen Kee (“Kee”), is suing hall of famer Barry Sanders (“Sanders”) for his alleged wrongful use of an iconic photograph—of himself—that was captured by Kee during a 1995 Detroit Lions game.
Federal Court Enjoins Corporate Transparency Act Reporting Requirements
In Texas Top Cop Shop Inc. et al. v. Garland et al., case number 4:24-cv-00478, a federal court sitting in the Eastern District of Texas, has enjoined the Corporate Transparency Act (“CTA”) beneficial ownership reporting requirements for now at least.
Playing Dirty: Samsung Wards Off Techiya’s Patent Infringement Claims With Successful Assertion of Unclean Hands
On November 5, 2021, Stanton Techiya, LLC filed suit against Samsung Electronics America, Inc. for patent infringement seeking approximately $500 Million Dollars in damages.