This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more
10/13/2020
/ 3D Printing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Foreign Manufacturers ,
Generic Drugs ,
Offshoring ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reshoring ,
Supply Chain ,
Tax Credits
On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more
1/30/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Civil Monetary Penalty ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Guidance ,
OIG ,
Patient Assistance Programs ,
Patient Safety ,
Pharmaceutical Industry