The nation’s largest pharmacy benefit managers (PBM) have drastically consolidated to a select and much-enriched few while wielding “enormous power and influence” over American consumers, the FTC illustrated in a 73-page report released Tuesday. Read More

To aid drug and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue. Read More

To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA), a risk management tool that supports the HF engineering process. Read More

Multiple and repeated violations found in Sun Pharmaceuticals’ Dadra, India facility during a December 2023 FDA inspection have resulted in a Warning Letter following the company’s inadequate responses to a Form 483 levied on it earlier this year. Read More

CBER has published an updated list of guidance topics for development during 2024. Read More

The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and other biologic products, including recommendations for high-level best practices for these studies. Read More

Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will comply with the US Supreme Court’s new decision on who ultimately is in charge of interpreting federal regulations — federal agencies or the courts and Congress. Read More

A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due to the Inflation Reduction Act’s (IRA) drug pricing provisions. Read More

The FDA on Tuesday approved Kisunla (donanemab-azbt), Eli Lilly’s once-monthly injection for adults with early symptomatic Alzheimer's disease (AD), along with earlier approvals of four other drugs for various conditions. Read More