- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
In this guidance, we, FDA (or the Agency), provide information to assist sponsors in developing vaccines to protect against global infectious diseases. The guidance will focus on development and licensure of vaccines targeted against infectious diseases or conditions endemic in areas outside the United States (U.S.). In addition, the guidance will clarify regulations, statutes and guidances applicable to the development of these products.
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-2011-D-0855.