|
|
|
| Advocacy > Federal > Regulatory > Practice issues > Vaccines > Conditional labels |
|
| |
Federal regulatory practice issues: Vaccines
|
| Updating label requirements for conditionally licensed vaccines |
Formal title: USDA Center for Veterinary Biologics (CVB) Notice No. Draft-004: Label Requirements for the Products Under Conditional Licenses
|
|
|
View USDA document (PDF, 1,030Kb)
|
| 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. |
| Response |
| View AVMA response to USDA (PDF) (June 6, 2005) |
| Conclusion |
| The CVB has no plans to go forward with the draft notice. |
|
|
| |
| | | |
| | | |
American Veterinary Medical Association
|
|