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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

Latest manuals from manuals+ curated for this brand.

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…

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…

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…

FDA MAPP 6702.1 Review of Risk Evaluation and Mitigation Strategy Owner’s Manual

October 19, 2024

FDA MAPP 6702.1 Review of Risk Evaluation and Mitigation Strategy Specifications Product Name: Manual of Policies and Procedures Center for Drug Evaluation and Research (MAPP 6702.1) Originating Office: Office of…

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…

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…

FDA K240280 Nano Check RSV Test Instructions

September 30, 2024

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) Number K240280 B Applicant Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information Product Code(s) Classification Regulation Section…

FDA E2B(R3) Electronic Transmission of Individual Case Safety Reports User Guide

September 15, 2024

FDA E2B(R3) Electronic Transmission of Individual Case Safety Reports Product Information Specifications: Product Name: FDA Regional Implementation Guide for E2B(R3) Electronic Transmission Compatibility: Drug and Biological Products Version: 3.1 Published…

FDA h:2250.1 Metered Mail Headquarters Instructions

August 23, 2024

FDA h2250.1 Metered Mail Purpose This Guide sets forth requirements for the metering of outgoing administrative mail at Headquarters locations in order to prepay USPS postage costs. Background In order…

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 Guide to Documents, Change Control, and Records Management

Guide

Comprehensive guide from the U.S. Food and Drug Administration (FDA) on managing documents, change control, Device Master Records (DMR), Device History Records (DHR), and Quality System Records (QSR) according to…

Understanding the Pharmaceutical Quality System (PQS) for FDA Inspections

Guide

An overview of the Pharmaceutical Quality System (PQS) presented by the FDA, focusing on CGMPs, ICH Q10, and FDA inspection strategies. Learn about quality expectations and regulatory requirements for pharmaceutical…

FDA Compliance Program 7356.002: Drug Manufacturing Inspections

Compliance Program

This document details the U.S. Food and Drug Administration's Compliance Program 7356.002, providing guidance on drug manufacturing inspections, quality assurance, CGMP requirements, and regulatory oversight for pharmaceutical products.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

manual

This FDA Staff Manual Guide (SMG 2130.11) details the Laboratory Quality Management System (LQMS) for the Food and Drug Administration, covering its purpose, scope, policies, definitions, responsibilities, and document history.

CDER MAPP 6020.14: Interdisciplinary Review Team for QT Studies Policy and Procedures

Manual

Official manual detailing the policies and procedures for the Center for Drug Evaluation and Research (CDER) Interdisciplinary Review Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

FDA Center for Tobacco Products Office of the Center Director: Organizations and Functions

Staff Manual

Official staff manual guide detailing the organizational structure and key functions of the Office of the Center Director (DCFA) within the U.S. Food and Drug Administration's Center for Tobacco Products.

FDA Regional Implementation Specifications for ICH E2B(R3) for Electronic Safety Report Submissions

Technical Specification

This document from the U.S. FDA provides technical specifications for submitting Individual Case Safety Reports (ICSRs) for drugs and biologics electronically, adhering to ICH E2B(R3) standards via the Electronic Submissions…

Guide for Preparing FDA Annual Reports on Laser Radiation Safety Testing

Guide

This guide provides instructions for manufacturers and importers on how to prepare and submit annual radiation safety testing reports for laser products and laser light show products to the U.S.…

FDA Opioid Analgesic REMS: Guidance for Professional Societies on Safe Prescribing and Disposal

Guidance

This document provides essential information from the FDA on the Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics, detailing safe disposal methods, continuing education for healthcare providers, and patient…

FDA Opioid Analgesic REMS Education Blueprint for Healthcare Providers

Educational Blueprint

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…

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…

Identification of Medicinal Products: Implementation and Use Guidance

guidance

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…