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Draft Guidance ,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