Document

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance revises the draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention'' issued on November 23, 2007.

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

83 FR 32136

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability,” thefederalregister.org (July 11, 2018), https://thefederalregister.org/documents/2018-14749/smallpox-variola-virus-infection-developing-drugs-for-treatment-or-prevention-draft-guidance-for-industry-availability.