The FDA has recently issued draft guidance (non-binding recommendations) for drug and biological product sponsors and computer programmers regarding the use of Machine Learning (ML) and artificial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.
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.
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.
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along with the Center for Biologics Evaluation and Research (CBER) and the Oncology Center of Excellence (OCE) issued draft guidance concerning expedited programs for serious conditions.
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).
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.
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.
On November 5, 2021, Stanton Techiya, LLC filed suit against Samsung Electronics America, Inc. for patent infringement seeking approximately $500 Million Dollars in damages.
The new small business finance rule passed by the CFPB requires “Covered” financial institutions to collect and report data on applications for credit for small businesses.
Texas Court Sets Aside DOL Rule Before Significant Increases to Exempt Worker Salaries Were Expected to Take Effect on January 1, 2025