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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

Selected manuals from manuals+ curated for this brand.

FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

August 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 presents…
FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module User Guide

August 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 Usage…
FDA 2004-N-0451 Food and Drug Instructions

FDA 2004-N-0451 Food and Drug Instructions

July 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 Registration…
FDA Viramune Oral Suspension Tablet Instructions

FDA Viramune Oral Suspension Tablet Instructions

July 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 does…
FDA Zyprexa Olanzapine Tablet Instructions

FDA Zyprexa Olanzapine Tablet Instructions

July 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 the…
FDA COVID-19 Flu Antigen Self Test Instruction Manual

FDA COVID-19 Flu Antigen Self Test Instruction Manual

July 1, 2024
FDA COVID-19 Flu Antigen Self Test Specifications: Product Name: QuickFinderTM COVID-19/Flu Antigen Self Test Intended Use: Qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B protein antigens Age…
FDA Birth Control Chart Instructions

FDA Birth Control Chart Instructions

June 28, 2024
FDA Birth Control Chart Product Information Specifications Product Name: Birth Control Guide (Chart) Website: www.fda.gov/birthcontrol Purpose: Provides high-level information about different birth control options for educational purposes Disclaimer: Not a…
FDA Food Safety Modernization Act (FSMA) Overview

FDA Food Safety Modernization Act (FSMA) Overview

Fact Sheet
An overview 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 food…
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

guidance
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 applications…