Home / Official Guidance / FDA / FDA Package Inserts / Page 2

Package Inserts & EUAs

FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. As part of their responsibility of ensuring that these products are safe and effective, they also approve product labeling, or package inserts.

Here we provide package inserts, product approvals, and other supporting documents listed alphabetically by vaccine, or use the filter to choose a specific vaccine.

Manufacturer’s contact information