On June 27, 2025, the U.S. Supreme Court held, in a 6-3 decision in Trump v. Casa, that federal courts lack the authority to issue nationwide injunctions under the Judiciary Act of 1789 (Judiciary Act). In doing so, the Court...more
At a Glance -
MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action.
Aggressive Action on the Table: If progress on voluntary price cuts...more
5/22/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Popular ,
Proposed Rules ,
Regulatory Reform ,
Trump Administration
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
2/13/2025
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Patient Privacy Rights ,
PHI ,
Risk Management
The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more
2/11/2025
/ Advertising ,
Consumer Protection Laws ,
Enforcement Actions ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Misbranding ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Telehealth
As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more
FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of...more
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
2/27/2024
/ Artificial Intelligence ,
Baby Products ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process
Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more