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GUIDANCE DOCUMENT

CVM GFI #35 Bioequivalence Guidance November 2006

Final
Docket Number:
FDA-1994-D-0317
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This document is intended to provide guidance for the design and analysis of in vivo bioequivalence studies.


Submit Comments

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:

Dockets Management
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-1994-D-0317.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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