The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more
9/8/2025
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Regulations ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Management
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
8/26/2025
/ Biotechnology ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Human Genome Project ,
Medical Devices ,
NIST ,
Qui Tam ,
Regulatory Violations ,
Settlement Agreements ,
Software ,
Vulnerability Assessments