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FDA Manuals & User Guides

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

tusi lesona fou mai manuals+ fa'atulagaina mo lenei ituaiga.

FDA Midazolam Fa'atonuga tui

FDA Midazolam Fa'atonuga tui

Oketopa 10, 2024
FDA Midazolam Injection Product Information Specifications Product Name: Midazolam Autoinjector Manufacturer: Rafa Laboratories, Ltd. Address: 3 Zeev Lev, Har Hotzvim Jerusalem, 9777515 Israel Revision Date: 11/2023 Reference ID: 5026561 Productā€¦
FDA K240280 Nano Siaki Fa'atonuga Su'ega RSV

FDA K240280 Nano Siaki Fa'atonuga Su'ega RSV

Setema 30, 2024
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) NumberĀ  K240280 B ApplicantĀ  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information ProductĀ Code(s) Classification RegulationĀ Sectionā€¦
FDA h:2250.1 Metered Mail Headquarters Faatonuga

FDA h:2250.1 Metered Mail Headquarters Faatonuga

Aokuso 23, 2024
FDA h2250.1 Meli Meli Faamoemoega O lenei Ta'iala o lo'o tu'uina atu ai mana'oga mo le fuaina o meli fa'alepulega i fafo i nofoaga o le Ofisa autu ina ia mafai ai ona totogi muamua le USPS po'o.tage costs. Background In orderā€¦
FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

Aokuso 15, 2024
FDA CFSAN Online Submission Module INTRODUCTION This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and illustrate how to assemble an OFAS Regulatory submission. COSM presentsā€¦
FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module User Guide

Aokuso 15, 2024
FDA CFSAN Submission Module Product Information Specifications Product Name: CFSAN Online Submission Module (COSM) Availability: 24 hours, 7 days a week Developed for: Transmitting submissions to FDA's CFSAN Product Usageā€¦
FDA 2004-N-0451 Mea'ai ma Vailaau Fa'atonuga

FDA 2004-N-0451 Mea'ai ma Vailaau Fa'atonuga

Iulai 31, 2024
FDA 2004-N-0451 Food and Drug Specifications Product Name: Food and Drug Administration Modernization Act of 1997 Recognition List Number: 062 Agency: Food and Drug Administration, HHS Product Usage Instructions Registrationā€¦
FDA Viramune Oral Suspension Tablet Faatonuga

FDA Viramune Oral Suspension Tablet Faatonuga

Iulai 6, 2024
FDA Viramune Oral Suspension Tablet Instructions Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information doesā€¦
FDA Zyprexa Olanzapine Tablet Faatonuga

FDA Zyprexa Olanzapine Tablet Faatonuga

Iulai 6, 2024
FDA Zyprexa Olanzapine Tablet Product Information Specifications: Product Name: ZYPREXA Generic Name: Olanzapine Form: Tablet, Orally Disintegrating Product Usage Instructions: Before starting ZYPREXA, read the Medication Guide provided with theā€¦
FDA Food Safety Modernization Act (FSMA) Ua umaview

FDA Food Safety Modernization Act (FSMA) Ua umaview

Pepa Fa'amatalaga
Ua umaview of the FDA Food Safety Modernization Act (FSMA) final rule on mitigation strategies to protect food against intentional adulteration, outlining key requirements, applicability, and resources for the foodā€¦
ORA Laboratory Manual Volume II: Faiga Puipuia

ORA Laboratory Manual Volume II: Faiga Puipuia

tusi lesona
This document outlines the preventive action procedure for the Office of Regulatory Science (ORS) laboratories, detailing the process for identifying, evaluating, and implementing actions to prevent nonconformities and improve theā€¦
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

taiala
This guide provides FDA specifications, recommendations, and general considerations for preparing and submitting Bioresearch Monitoring (BIMO) clinical data in electronic format for new drug applications (NDAs) and biologics license applicationsā€¦