Erdman Matthew M, Clough Nancy E, Hauer Paul J
J Am Vet Med Assoc. 2020 Dec 1;257(11):1142-1147. doi: 10.2460/javma.2020.257.11.1142.
The USDA continues to consider and implement regulatory pathways for evolving scenarios, needs, and technologies. The intent of this report is to make veterinarians and other users of veterinary biologics aware of recent regulatory additions and changes, particularly in the area of veterinary vaccines. These include new licensure pathways to increase product availability, standardization of labeling, and increased transparency regarding adverse event reports and the efficacy and safety studies accepted by the USDA for product licensure. This report did not undergo scientific peer review.
美国农业部继续针对不断变化的情况、需求和技术考虑并实施监管途径。本报告旨在让兽医及兽医生物制品的其他使用者了解近期的监管新增内容和变化，尤其是在兽用疫苗领域。这些包括增加产品可及性的新许可途径、标签标准化，以及在不良事件报告、美国农业部认可的用于产品许可的功效和安全性研究方面提高透明度。本报告未经过科学同行评审。
