FDA Commissioner Marty Makary announced policy shifts that ease the path to market for certain digital health technologies, including AI- and generative AI-enabled clinical decision support software (CDS) and consumer...more
1/12/2026
/ Artificial Intelligence ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mobile Health Apps ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Software Developers
The U.S. Food and Drug Administration announced a major shift in its approach to real‑world evidence (RWE). In new guidance for certain medical device submissions, FDA will accept RWE without always requiring identifiable,...more
12/17/2025
/ Biologics ,
Clinical Trials ,
Data Privacy ,
Data Protection ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Guidance ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Privacy-By-Design ,
Regulatory Requirements
The U.S. Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) held a public meeting on “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,” with a particular focus on a...more
11/12/2025
/ Artificial Intelligence ,
Bias ,
Clinical Trials ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Mental Health ,
Regulatory Requirements ,
Risk Management
FDA’s recent announcement that it is undertaking sweeping reforms and a major enforcement initiative targeting allegedly misleading direct-to-consumer (DTC) prescription drug advertising will have significant implications for...more
9/15/2025
/ Advertising ,
Artificial Intelligence ,
Compliance Monitoring ,
Direct to Consumer Sales ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Social Media
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
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more