On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more
8/6/2025
/ Biotechnology ,
Corporate Counsel ,
Cybersecurity ,
Cybersecurity Maturity Model Certification (CMMC) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
NIST ,
Popular ,
Whistleblowers
Private capital firms focused on investment and operations within the Life Science and Healthcare industries face complex compliance, operational, and business risks. To help clients navigate this evolving environment, White...more
8/5/2025
/ Acquisitions ,
Artificial Intelligence ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Life Sciences ,
Mergers ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Private Equity Firms
Overview -
- The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025.
- The...more
5/22/2025
/ Artificial Intelligence ,
Clinical Trials ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
5/6/2025
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Popular ,
Private Equity ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Tariffs ,
Technology ,
Trump Administration