Business · 28/07/1999

Substantial Evidence of Effectiveness of New Animal Drugs

The US Food and Drug Administration (FDA) is updating its animal drug regulations to clarify the definition of 'substantial evidence' and encourage the submission of new animal drug applications, as mandated by the Animal Drug Availability Act of 1996. The changes aim to facilitate the approval of new animal drugs, including single-ingredient and combination products, and promote dose range labeling.