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Federal regulatory practice issues: Vaccines

Improved vaccine labeling
Formal title:
The U.S. Department of Agriculture Veterinary Services Memorandum Draft No. 336 "Electronic Freedom of Information Act (EFOIA) Involving Veterinary Biological Products."

View USDA document (PDF, 20Kb)

Brief Description

The USDA is providing draft guidelines to allow for the preparation and electronic publishing of summaries for all efficacy and safety studies used to support vaccine licensing.

The AVMA commends the CVB for its progress on improving vaccine labels. The AVMA has repeatedly articulated the need for biologic labels to communicate an appropriate expectation of product performance to users of the products.

Full AVMA Letter:
View AVMA's letter to USDA (PDF) (April 25, 2008)
Status
AVMA responded on April 25, 2008.