Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry ( 199) entitled "Animal Generic Drug User Fees and Fee Waivers and Reductions." The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency's good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time.