Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
3/26/2025
/ Compliance ,
Draft Guidance ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Public Health ,
Regulatory Requirements ,
Risk Management ,
Warning Letters
The Georgia Department of Community Health (“DCH”) board recently introduced proposed updates to long-term care facility standards, impacting background check requirements, care models for at-risk youth, and staffing...more
2/27/2025
/ Assisted Living Facilities (ALFs) ,
Change of Ownership ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Workers ,
Medicaid ,
Mental Health ,
Nursing Homes ,
Proposed Rules ,
Regulatory Requirements ,
Skilled Nursing Facility ,
Therapeutic Services