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federal_register: 2018-14749

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-14749 Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention." The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance revises the draft guidance for industry entitled "Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention" issued on November 23, 2007. 2018-07-11 2018 7 https://www.federalregister.gov/documents/2018/07/11/2018-14749/smallpox-variola-virus-infection-developing-drugs-for-treatment-or-prevention-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2018-07-11/pdf/2018-14749.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention." The purpose of this draft guidance is to...  

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