Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
1/22/2025
/ Artificial Intelligence ,
Biologics ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
Whistleblowers
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
7/18/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Reimbursements ,
Section 340B ,
Shareholders
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
2/22/2024
/ Affordable Care Act ,
Artificial Intelligence ,
Chevron Deference ,
Data Privacy ,
Data Security ,
Digital Health ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements ,
Startups ,
Technology
On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more