Vaccines Licensed for Use in the United States
The FDA maintained a consolidated list of vaccines licensed for use within the United States, including both product names and trade names.
This information affects vaccine manufacturers, regulatory affairs professionals, and supply chain managers responsible for the distribution of licensed biologics in the US market.
Maintaining an accurate list of licensed products is essential for verifying legal marketing status and ensuring compliance with federal biologics regulations. For industry professionals, these updates serve as an official reference point for authorized trade names, which may impact labeling, advertising, and import/export documentation. This suggests the importance of tracking administrative changes or additions to the licensed biologics portfolio to prevent discrepancies in regulatory filings.
Regulatory affairs teams should cross-reference this list against current Biologics License Applications (BLAs) to ensure internal registries match the FDA's current licensing status. QA teams should verify that trade names on packaging and labeling remain consistent with the officially licensed terminology.
The product name and trade name of vaccines licensed for use in the United States.
Open in openFDA / FDA.gov