- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, FDA, are providing you, manufacturers of viral vaccines, guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use.
This guidance applies to the development of viral vaccines for the prevention and treatment of infectious diseases that are regulated by the Office of Vaccines Research and Review (OVRR) of the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).
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-0223.