Generic Animal Drug and Patent Term Restoration Act; Ninth Policy Letter; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a ninth policy letter, dated June 27, 1995, concerning implementation of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA). The ninth policy letter states the revised policy of the Center for Veterinary Medicine (CVM) on the environmental information to be submitted by sponsors for generic animal drug products. The agency is soliciting comments on the policy letter.