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GUIDANCE DOCUMENT

CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Guidance GL52 September 2014

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2014-D-1352
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This supplement to GFI #224 (VICH GL52) provides examples for illustrating statistical concepts described in the guidance.


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-2014-D-1352.

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