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Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox

التفاصيل البيبلوغرافية
العنوان: Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox
المؤلفون: Kirk M Chan-Tack, Shirley Seo, Laine Myers, David McMillan, Su-Young Choi, Julian J. O'Rear, Patrick R. Harrington, Adam Sherwat, Debra Birnkrant, Hanan Ghantous
المصدر: The Lancet Infectious Diseases. 19:e221-e224
بيانات النشر: Elsevier BV, 2019.
سنة النشر: 2019
مصطلحات موضوعية: 0301 basic medicine, Drug, medicine.medical_specialty, media_common.quotation_subject, MEDLINE, Disease, Isoindoles, Antiviral Agents, Food and drug administration, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Smallpox, 030212 general & internal medicine, Disease Eradication, Intensive care medicine, Drug Approval, media_common, United States Food and Drug Administration, business.industry, Tecovirimat, medicine.disease, United States, Treatment Outcome, 030104 developmental biology, Infectious Diseases, Benzamides, Regulatory Pathway, business
الوصف: The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.
تدمد: 1473-3099
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::856e39dcdb98184a25ad65d47ef931fb
https://doi.org/10.1016/s1473-3099(18)30788-6
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....856e39dcdb98184a25ad65d47ef931fb
قاعدة البيانات: OpenAIRE
الوصف
تدمد:14733099