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 March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the...more
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
On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more
On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more