In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
11/19/2019
/ Biologics ,
Chief Compliance Officers ,
Compliance ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Diagnostic Tests ,
Export Controls ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Risk Assessment ,
Risk Management ,
Supply Chain