FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more
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
On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more