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GUIDANCE DOCUMENT

Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention July 2018

Draft

Not for implementation. Contains non-binding recommendations.

Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of smallpox (variola virus) infection.2 20 Clinical efficacy trials of drugs for the treatment or prevention of 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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.