Tag: FDA

Nationwide Recall of Shredded Cheese Due to Potential Metal Contamination

Great Lakes Cheese recalls shredded cheese nationwide amid FDA warning of metal fragments; affects major brands including Walmart and Aldi. No reported illnesses.

FDA Reassigns Director of Office of Nonprescription Drugs Amid Strategic Shift

The FDA has reassigned the director of its Office of Nonprescription Drugs to a medical devices leadership role, highlighting a strategic shift toward affordability and regulatory realignment. This change may impact drug approval policies and insurance regulatory compliance.

FDA Names Tracy Beth Høeg as New Leader of Center for Drug Evaluation and Research

The FDA appoints Tracy Beth Høeg as the new director of CDER, marking the fifth leadership change this year, impacting drug regulation and insurance sectors.

Georgia Medicare Kickback Sentencing & FDA Updates on Lead Cookware and Primate Testing

Georgia man sentenced for $24M Medicare genetic testing kickback scheme; FDA warns on lead in cookware; new guidance limits primate testing in drug development.

US Congress Advances Healthcare Legislation; FDA Launches Agentic AI; CMS Updates Payments

Overview of US Congressional healthcare legislation, FDA's AI modernization, CMS payment reforms, and key trade agreements influencing the insurance landscape in 2025.

2025 Changes in COVID-19 Vaccine Eligibility and Off-label Use in the U.S.

Explore the 2025 U.S. updates on COVID-19 vaccine eligibility, off-label use, and insurance coverage ensuring broad access amid regulatory changes.

FDA Approves Leucovorin for Autism Amid Investment and Regulatory Clarifications

FDA approves prescription leucovorin for autism treatment; HHS addresses investment and regulatory concerns involving CMS administrator Dr. Mehmet Oz amid public discourse.

US 2025-26 Flu Season Vaccination Guidance and Insurance Coverage Update

Explore expert insights on the 2025-26 US flu vaccine updates, CDC recommendations, insurance coverage, and vaccine policy changes affecting the flu season.

Supreme Court Procedural Rulings Favor Corporate Access to Federal Courts

Recent Supreme Court procedural rulings lower barriers for corporate lawsuits, enabling strategic venue choices and expanded standing, impacting environmental and FDA regulatory challenges in U.S. federal courts.

FDA Updates COVID Vaccine Policy; Medicare Fraud Sentencing; Immunization Funding Growth

FDA refocuses COVID vaccine approvals on high-risk groups with new evidence requirements. Medicare fraud case results in sentencing for $3.2M scheme. Lower-income countries increase self-funded vaccine investments. Bipartisan prior authorization reform bill returns in Congress.