Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance ( 173) entitled "Guidance For Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)." This draft guidance describes how FDA intends to implement the Federal Food, Drug, and Cosmetic Act (the act) as it relates to animal drug sponsor fees.