FDA Manuals & User Guides

FDA Mens Plain Face Cream Owner’s Manual

January 24, 2025

FDA Mens Plain Face Cream Specifications Product Type: HUMAN OTC DRUG TOPICAL Item Code (Source): NDC:84522-526 Active Ingredient: Salicylic acid 2% Inactive Ingredients: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORPHENESIN, GLYCERIN,…

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…

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide

January 2, 2025

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide Purpose This document is intended to support users of the Lilypad™ VR experience. It outlines the technical requirements, processes…

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…

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…

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…

Making ACE Work for You: Importing FDA Regulated Products Guide

Guide

A comprehensive guide from the U.S. Food and Drug Administration (FDA) explaining how to effectively use the Automated Commercial Environment (ACE) for importing FDA-regulated products, covering key processes, common issues,…

ANDA Submissions: Content and Format Guidance for Industry

Guidance

U.S. FDA guidance for industry on Abbreviated New Drug Applications (ANDAs), detailing content and format requirements using the Common Technical Document (CTD) structure for pharmaceutical product submissions.

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…