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Federal regulatory practice issues: Vaccines

Labeling of equine influenza and swine influenza vaccines
Formal title:
USDA Center for Veterinary Biologics Notice Draft No. 313

View Center for Veterinary Biologics notice draft No. 313 (PDF)

Summary

The USDA Center for Veterinary Biologics released a draft notice notifying veterinary biologics licensees, permittees, and applicants of a change in labeling of veterinary biologics containing swine influenza virus or equine influenza virus. The notice does not pertain to autogenous products containing equine and/or swine influenza virus.

The changes would require labels to contain information regarding the subtypes and strains, or the parent strain of recombinant/resortant/subunit products.

It is the opinion of the AVMA that the proposal will likely enhance effective vaccination strategies for currently circulating influenza viruses in swine and horses.

Response
View AVMA response to USDA (PDF)
Status
AVMA responded on August 6, 2007.