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The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.

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FDA manuals

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FDA Bio-Self COVID-19 Antigen Home Test Manual Manual

FDA Bio-Self COVID-19 Antigen Home Test Manual Manual

Iuni 22, 2023
FDA Bio-Self COVID-19 Antigen Home Test Instruction Manual INTENDED USE The Bio-SelfTM COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen…
FDA DAYVIGO Tablet Instruction Manual

FDA DAYVIGO Tablet Instruction Manual

Ianuari 13, 2023
FDA DAYVIGO Tablet HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DAYVIGO® safely and effectively. See full prescribing information for DAYVIGO®. DAYVIGO® (lemborexant)…
FDA CVM eSubmitter Master File Fa'aoga Taiala

FDA CVM eSubmitter Master File Fa'aoga Taiala

Novema 25, 2022
FDA CVM eSubmitter Master File Folasaga Le Matai File O le tusi e maua ai se auala e teu ai le Matai File information to be reused across submissions and associated books. Reusing this data makes…
FDA COVID-19 Nano Fa'atonuga Tusi Taiala

FDA COVID-19 Nano Fa'atonuga Tusi Taiala

Novema 24, 2022
FDA COVID-19 Nano Test Instruction Manual The Nano Test for COVID-19 will be performed at Nanobiosym Precision Testing Services, located at 245 First Street, Suite 175, Cambridge, MA 02142, that…
FDA Food Facility Register User Guide

FDA Food Facility Register User Guide

Aokuso 29, 2022
FDA Food Facility Registration IMPORTANT INSTRUCTION Step 1 – Select the registration you want to update Once you are logged in to FDA Industry Systems/your Online Account Administration (OAA) account,…