On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more
11/7/2023
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Bundling Rules ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Kickbacks ,
Medical Devices ,
Medicare ,
OIG ,
Patient Access ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements
The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more
6/13/2023
/ Clinical Trials ,
Comment Period ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Healthcare ,
Innovation ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Public Comment ,
Research and Development