Tag: FDA

2026 U.S. Legislative and Regulatory Outlook: Implications for Insurance and Infrastructure

Comprehensive 2026 U.S. legislative and regulatory forecast impacting insurance, healthcare, infrastructure, and technology sectors. Key updates on ACA subsidies, FDA reauthorization, transportation, and trade policies shaping compliance and market strategies.

CMS Launches ACCESS Model to Advance Technology-Supported Chronic Care

CMS introduces the ACCESS Model to improve Medicare chronic care with digital health innovation and outcome-based payments starting 2026.

Insurance Challenges Delay FDA-Approved Scoliosis Surgery Coverage

Discover the insurance challenges surrounding FDA-approved vertebral body tethering for scoliosis. Understand insurer denial reasons, clinical outcomes, and impact on patient care.

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.