Considerations for Plasmid DNA Vaccines for Infectious Disease Indications Guidance for Industry November 2007
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance describes our current recommendations concerning preclinical development and testing of DNA vaccines to prevent infectious diseases. This guidance supercedes the 1996 Points to Consider document. In addition, this guidance finalizes the draft guidance of the same title dated February 2005.
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: 2005D-0047.