Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests.

Yang, Tony; Kessler, Larry G; Thompson, Matthew J; Lutz, Barry R

Yang, Tony; Kessler, Larry G; Thompson, Matthew J; Lutz, Barry R.

Afiliación

Yang T; Biomedical Regulatory Affairs Program, University of Washingtongrid.34477.33, Seattle, Washington, USA.
Kessler LG; School of Public Health, University of Washingtongrid.34477.33, Seattle, Washington, USA.
Thompson MJ; Department of Pharmacy, University of Washington, Seattle, Washington, USA.
Lutz BR; Department of Family Medicine, University of Washingtongrid.34477.33, Seattle, Washington, USA.

J Clin Microbiol ; 60(5): e0188421, 2022 05 18.

Article en En | MEDLINE | ID: mdl-34911365

Asunto(s)

COVID-19; Gripe Humana; COVID-19/diagnóstico; Humanos; Gripe Humana/diagnóstico; Laboratorios; Pandemias; SARS-CoV-2

Palabras clave

FDA; home test; influenza; regulation; study design

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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Gripe Humana / COVID-19 Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: J Clin Microbiol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos

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