- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Drug Evaluation and Research
The purpose of this guidance is to assist sponsors in the clinical development of drugs for treatment or prevention of smallpox (variola virus) infection. Clinical efficacy trials of drugs for treating or preventing smallpox are not feasible and challenge studies in healthy subjects are unethical; therefore, drugs for these indications should be developed and approved under the regulations commonly referred to as the Animal Rule (21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biologics). This guidance serves as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.
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-2018-D-1835.