- Docket Number:
- FDA -2006-D-0299
- Issued by:
Guidance Issuing OfficeCenter 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.
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 -2006-D-0299.