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Guidance Issuing OfficeCenter for Veterinary Medicine
This document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies (biowaivers) for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients (APIs) considered to be soluble in aqueous media (water soluble APIs). This document expands upon CVM’s Guidance for Industry (GFI) #35, “Bioequivalence Guidance,” to include biowaivers for soluble powder oral dosage form products as well as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media, and it offers particular focus on criteria for the waiver of the requirements for submitting in vivo bioequivalence study data. This guidance does not address Type A medicated articles manufactured from active pharmaceutical ingredients considered to be insoluble in aqueous media.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-3764.