Zdrowie i gospodarka · 20.12.2010
Unapproved Animal Drugs
The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. FDA is concerned that the safety and effectiveness of these actively-marketed products has not been demonstrated. Therefore, the Agency is requesting comments on approaches for increasing the number of legally-marketed animal drug products, as well as on the use of enforcement discretion for some unapproved animal drug products in certain limited circumstances.