Regulatory Brief

 Evaluating the Compatibility of Vaccine Components in Combination Biological Products Formed by Assembling Previously Licensed Products


Formal title: Veterinary Services Memorandum No. 800.203; General Licensing Considerations: Antigen Interference


Brief Description:

On January 20, 2006 the CVB published a revised draft guidance document for evaluating the compatibility of components in combination biological products formed by assembling previously licensed products.

AVMA Response:

The AVMA values clinically relevant enhancements to vaccine efficacy and safety; however, the AVMA is concerned the proposed changes could limit the availability of polyvalent vaccines. The AVMA encouraged the CVB to continue discussion with stakeholders prior to finalizing this memorandum.

Update:

In August/September 2006, the CVB published a second revised draft guidance document for evaluating the compatibility of components in combination biological products formed by assembling previously licensed products. 

Background Documents:

View Veterinary Services Memorandum (PDF)

View AVMA's response to USDA (PDF) (February 27, 2006)

View AVMA's second response to USDA (PDF) (September 08, 2006)

Status

AVMA responded on February 27, 2006 and September 8, 2006. In August/September 2006, the CVB published a second revised draft guidance document for evaluating the compatibility of components in combination biological products formed by assembling previously licensed products. The AVMA believes the document is an improvement upon the initial draft; however, some of the AVMA's initial questions remain. A final CVB document (PDF) was published on January 16, 2007.