On March 27, 2025, the United States Department of Health and Human Services (HHS) announced a “dramatic restructuring” that will result in a reduction in agency workforce combined with significant internal restructuring. The...more
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
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
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
3/5/2020
/ Administrative Proceedings ,
Best Practices ,
Biologics ,
China ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Supply Chain
Surprising nearly everyone, FDA has reopened a long dormant discussion regarding the meaning of the term “natural” in the labeling of food. Today’s Federal Register contains a notice from FDA that the agency has officially...more
Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive...more
9/10/2015
/ Animal Food ,
CGMP ,
Compliance ,
Federal Register ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Manufacturers ,
Product Packaging
On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more