In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more
2/13/2025
/ Artificial Intelligence ,
Clinical Trials ,
Drug Safety ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law.
In this installment of The Good Bot, host Brett Mason is joined by Partner...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law.
In this installment, Brett is joined by Partner Judy O'Grady and Associate...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives.
Originally published in Law360 - September 11, 2023....more
12/11/2023
/ Advertising ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Statements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Social Media
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
Why It Matters -
In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
10/7/2020
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Health Record Incentives ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Machine Learning ,
OCR ,
Security Risk Assessments
On March 18, the Food and Drug Administration (FDA) issued guidance in recognition of the extraordinary challenges that have impacted ongoing medical research in light of the coronavirus pandemic. “FDA Guidance on Conduct of...more