FDA Releases Draft Guidance on Randomized Controlled Drug Trials in Routine…
Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials…
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United States Agencies Release New Final Rules Implementing the MHPAEA
The United States Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) released…
CMS Proposes Changes to Reporting and Returning Medicare Parts A and B…
Tucked into the Physician Fee Schedule is a provision that should be of interest to False Claims Act attorneys. Regarding Medicare…
St. Peter’s Health Reaches $10.8 Million False Claims Act Settlement for…
St. Peter’s Health in Helena, Montana recently reached a $10.8 million False Claims Act settlement over self-reported False Claims…
Strategic Allocation of Opioid Settlement Funds: A Conversation with…
As the opioid epidemic continues to devastate communities, attention has turned to how best to allocate the billions in opioid…
John Marshall Oncology Unscripted: CROs and the Rising Costs of Clinical…
Clinical research organizations (CROs) have become an essential yet contentious part of modern medical research. Originating in…
NIH Scientific Integrity Policy 2024: Eliminates Detailed Sections on…
The National Institutes of Health (NIH) has released a comprehensive update to its Scientific Integrity Policy, marking a…
CMS Releases Prices for Inflation Reduction Act Drug Price Negotiation…
On Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10…
HHS OCR Levies $115,200 CMP Against American Medical Response for HIPAA…
Recently, the United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a $115,200 civil…
The Inflation Reduction Act (IRA) and Its Broader Impact on Innovation,…
On October 8, 2024, PhRMA held a media briefing to address growing concerns over the Inflation Reduction Act (IRA) and its effects…