2004D-0283 - Draft Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability
FDA Comment Number : EC1
Submitter : Ms. Linda Duple Date & Time: 10/12/2004 02:10:35
Organization : Bimeda, Inc.
Drug Industry
Category :
Issue Areas/Comments
The interpretation would be clearer if distinction/separation could be made between soluble powders and Type A Medicated Articles.