Regulatory Brief

 Updating Label Requirements for Conditionally Licensed Vaccines


Formal title: USDA Center for Veterinary Biologics (CVB) Notice No. Draft-004: Lable Requirements for the Products Under Conditional Licenses


Summary:

The USDA CVB is proposing to update the label requirements for conditionally licensed vaccines, that is, those vaccines that are marketed with a reasonable expectation of efficacy in order to meet an emergency condition, limited market, local situation, or other special circumstance.

The AVMA commends the CVB for offering a proposal to differentiate labels of conditionally licensed vaccines from labels of fully licensed vaccines.

Background Documents:

View AVMA response to USDA(PDF) (June 6, 2005)

Conclusion:

The CVB has no plans to go forward with the draft notice.