Key Considerations for Reshoring U.S. Drug Manufacturing
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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
Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more
With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more
• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more