FDA Manuals & User Guides

User manuals, setup guides, troubleshooting help, and repair information for FDA products.

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FDA manuals

Latest posts, featured manuals, and retailer-linked manuals for this brand tag.

FDA Anti Aging Cream Owner’s Manual

FDA Anti Aging Cream Owner’s Manual

January 24, 2025
FDA Anti Aging Cream Product Specifications Product Name: Anti-Aging Cream Product Type: Topical Cream Active Ingredient: Niacinamide Strength: 5 g in 100 g Inactive Ingredients: Sesame Oil, Glycerin, Chlorphenesin, Palmitoyl Tripeptide-1, Palmitoyl Pentapeptide-4 Packaging Options: 5 g, 15 g, 30…
Brand: FDA
FDA DTP-1 Lighting the Development Pathway User Guide

FDA DTP-1 Lighting the Development Pathway User Guide

November 27, 2024
Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs Karthika Natarajan Staff Fellow, DTP-1 | ORS | OGD CDER | U.S. FDA Facilitating Generic Drug Product Availability through Product Specific Guidances (PSGs)– April 25, 2024 Combination Products A…
Brand: FDA
FDA Information Technology Strategy User Guide

FDA Information Technology Strategy User Guide

November 13, 2024
FDA Information Technology Strategy for Fiscal Years 2024 to 2027 Message from the CIO I am pleased to share our annual publication of the FDA IT Strategy for FY 2024 — FY 2027. This enterprise plan, shaped by the FDA’s…
Brand: FDA
FDA 6001.2 Network of Experts Instructions

FDA 6001.2 Network of Experts Instructions

October 28, 2024
FDA 6001.2 Network of Experts Specifications Name: Center for Drug Evaluation and Research (CDER) Network of Experts (NoE) Document: MAPP 6001.2 Rev. 2 Effective Date: 10/23/15; 10/8/21; 2/1/24 Product Information Categories of Issue Requests Category A: General topics in Engineering,…
Brand: FDA
FDA Patient Medication Information User Guide

FDA Patient Medication Information User Guide

October 23, 2024
Patient Medication Information Product Information Specifications: Product Name: Patient Medication Information (PMI) Type: FDA-approved Medication Guide Storage: Online central repository managed by FDA Accessibility: Freely accessible to the public Product Usage Instructions: What does the proposed rule require? The…
Brand: FDA
FDA CDER Electronic Record Keeping Systems Owner’s Manual

FDA CDER Electronic Record Keeping Systems Owner’s Manual

October 19, 2024
FDA CDER Electronic Record Keeping Systems PURPOSE This MAPP documents CDER’s Electronic Records Keeping Systems (ERKS) and outlines the policies and procedures for its governance. This includes the following: Definition of a Record and ERKS Identification of the various systems…
Brand: FDA
FDA CDER NextGen Portal User Guide

FDA CDER NextGen Portal User Guide

October 19, 2024
FDA CDER NextGen Portal Specifications: Product Name: CDER NextGen Portal Supported Browsers: Internet Explorer, Google Chrome, Mozilla Firefox Security Feature: Multi-Factor Authentication (MFA) through email Product Usage Instructions Requesting a Login: To request a login on the CDER NextGen Portal:…
Brand: FDA
FDA Midazolam Injection Instructions

FDA Midazolam Injection Instructions

October 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 Product Usage Instructions Step 1: Preparation Ensure you have the Midazolam…
Brand: FDA
FDA Opioid Analgesic REMS Education Blueprint for Healthcare Providers

FDA Opioid Analgesic REMS Education Blueprint for Healthcare Providers

Educational Blueprint • August 18, 2025
This document outlines the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) educational blueprint for healthcare providers. It covers essential knowledge for treating and monitoring patients with pain, including pain management fundamentals, opioid risks, safe prescribing practices, patient counseling, and addiction…
Brand: FDA
FDA Food Safety Modernization Act (FSMA) Overview

FDA Food Safety Modernization Act (FSMA) Overview

Fact Sheet • August 6, 2025
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 industry.
Brand: FDA
Identification of Medicinal Products: Implementation and Use Guidance

Identification of Medicinal Products: Implementation and Use Guidance

guidance • August 5, 2025
Guidance for industry on the implementation and use of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. This document outlines the FDA's approach to aligning with these standards for improved global data exchange, drug safety, and supply chain…
Brand: FDA