In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more
7/18/2025
/ Anti-Kickback Statute ,
Audits ,
Billing ,
Clinical Laboratories ,
Compliance ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medical Necessity ,
Medicare ,
OIG ,
PAMA ,
Regulatory Requirements
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
6/24/2025
/ Clinical Trials ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Priorities List (NPL) ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements
This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more