FDA Information Technology Strategy User Guide
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 2024ā¦
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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.
FDA manuals
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FDA 6001.2 Network of Experts Instructions
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 Informationā¦
FDA Patient Medication Information User Guide
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 Productā¦
FDA CDER Electronic Record Keeping Systems Owner’s Manual
FDA CDER Electronic Record Keeping Systems PURPOSE This MAPP documents CDERās Electronic Records Keeping Systems (ERKS) and outlines the policies and procedures for its governance. This includes the following: Definitionā¦
FDA MAPP 6702.1 Review of Risk Evaluation and Mitigation Strategy Owner’s Manual
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 ofā¦
FDA CDER NextGen Portal User Guide
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 aā¦
FDA Midazolam Injection Instructions
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 Check RSV Test Instructions
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 E2B(R3) Electronic Transmission of Individual Case Safety Reports User Guide
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 Publishedā¦
FDA h:2250.1 Metered Mail Headquarters Instructions
FDA h2250.1 Metered MailĀ 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 orderā¦
Making ACE Work for You: Importing FDA Regulated Products 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,ā¦
ANDA Submissions: Content and Format Guidance for Industry
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
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 toā¦
Understanding the Pharmaceutical Quality System (PQS) for FDA Inspections
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 pharmaceuticalā¦
FDA Compliance Program 7356.002: Drug Manufacturing Inspections
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
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
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 repolarizationā¦
FDA Center for Tobacco Products Office of the Center Director: Organizations and Functions
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
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 Submissionsā¦
Guide for Preparing FDA Annual Reports on Laser Radiation Safety Testing
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.ā¦
FDA Opioid Analgesic REMS: Guidance for Professional Societies on Safe Prescribing and Disposal
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 patientā¦
FDA Opioid Analgesic REMS Education Blueprint for Healthcare Providers
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, includingā¦