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GUIDANCE DOCUMENT

CVM GFI #74 (VICH GL4 ) Stability Testing of New Veterinary Dosage Forms September 1999

Final
Docket Number:
FDA -2006-D-0299
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This document is an annex to the VICH parent stability guidance, Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL3) and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products.

A new dosage form is defined as a drug product which is a different pharmaceutical product type, but contains the same active substance as included in the existing drug product approved by the pertinent regulatory authority.


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 -2006-D-0299.

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