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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

Akwụkwọ ntuziaka kacha ọhụrụ si manuals+ kwadoro maka ika a.

Akwụkwọ ntuziaka onye nwe ude dị larịị nke FDA Mens

Jenụwarị 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,…

Akwụkwọ ntuziaka onye nwe ude nke FDA Anti Aging

Jenụwarị 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 ntuziaka onye ọrụ

Jenụwarị 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 na-amụnye ntuziaka onye ọrụ ụzọ mmepe

Nọvemba 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…

Ntuziaka onye ọrụ teknụzụ ozi FDA

Nọvemba 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 nke ndị ọkachamara ntuziaka

Ọktoba 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…

Ntuziaka onye ọrụ ozi ọgwụ onye ọrịa FDA

Ọktoba 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…

Akwụkwọ ntuziaka onye nwe ihe ndekọ ndekọ elektrọnik FDA CDER

Ọktoba 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 Akwụkwọ ntuziaka onye nwe nke nyocha ihe egwu na mbelata

Ọktoba 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…

Ntuziaka onye ọrụ FDA CDER NextGen Portal

Ọktoba 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…

Akwụkwọ ntuziaka Bacteriological Analytical Isi nke 23: Ụzọ maka ịchọ mma - FDA

Akwụkwọ ntuziaka

Ntuziaka zuru oke na-akọwapụta ụzọ nnwale microbiological maka ngwaahịa ịchọ mma, gụnyere sample nkwadebe, ngụkọ, njirimara nke ụmụ nje, na preservative nrụpụta ọrụ, dị ka US Food & Drug Administration (FDA) bipụtara.

Ntuziaka FDA ESG NextGen AS2 maka ndị ọrụ ụlọ ọrụ - Ụdị 2.0

Nduzi

Ntuziaka gọọmentị maka ndị ọrụ ụlọ ọrụ maka ịnyefe data site na AS2 na FDA's Electronic Submission Gateway (ESG) NextGen. Na-ekpuchi nhazi, usoro ntinye, na nchọpụta nsogbu.

Ime ACE na-arụ ọrụ maka gị: Mbubata ntuziaka ngwaahịa FDA kwadoro

Nduzi

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,…

Ntinye ANDA: Ntuzi Ọdịnaya na Usoro maka Mmepụta

Nduzi

Ntuziaka FDA US maka ụlọ ọrụ na Ngwa Ọgwụ Ọgwụ ọhụrụ (ANDAs), na-akọwapụta ọdịnaya na usoro chọrọ site na iji usoro nka nka na-emekarị (CTD) maka ntinye ngwaahịa ọgwụ.

FDA Guide to Documents, Change Control, and Records Management

Nduzi

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…

Ịghọta Sistemụ Ogo Ọgwụ (PQS) maka nyocha FDA

Nduzi

Nfefeview 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…

Mmemme nnabata FDA 7356.002: Nnyocha nrụpụta ọgwụ

Compliance Program

Akwụkwọ a na-akọwapụta mmemme nnabata nke nchịkwa nri na ọgwụ US 7356.002, na-enye ntụzịaka na nyocha nrụpụta ọgwụ, mmesi obi ike, ihe CGMP chọrọ, yana nleba anya nhazi maka ngwaahịa ọgwụ.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

akwụkwọ ntuziaka

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 Otu maka amụma na usoro ọmụmụ QT

Akwụkwọ ntuziaka

Akwụkwọ ntuziaka na-akọwapụta amụma na usoro maka Center for Drug Evaluation and Research (CDER) Interdisciplinary Re.view 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.

Nkọwapụta mmejuputa mpaghara FDA maka ICH E2B(R3) maka ntinye mkpesa nchekwa eletrọnịkị

Nkọwa nka nka

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

Nduzi

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.…