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Llawlyfrau a Chanllawiau Defnyddwyr FDA

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.

Awgrym: cynnwys y rhif model llawn sydd wedi'i argraffu ar eich label FDA i gael y paru gorau.

Cymorth FDA

Safle swyddogol: https://www.fda.gov/
Cymorth cyffredinol: https://www.fda.gov/about-fda/contact-fda
Ffôn cymorth: 1-888-463-6332 — Mon-Fri 8:00am - 4:30pm ET
E-bost cefnogi: webpost@oc.fda.gov
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Llawlyfrau FDA

Llawlyfrau diweddaraf gan manuals+ wedi'i guradu ar gyfer y brand hwn.

Llawlyfr Perchennog Hufen Wyneb Plaen FDA Dynion

Ionawr 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,…

Llawlyfr Perchennog Hufen Gwrth Heneiddio FDA

Ionawr 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 Headset Realiti Cymysg 128 GB Canllaw Defnyddiwr

Ionawr 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 Canllaw i Ddefnyddwyr Goleuo'r Llwybr Datblygu

Tachwedd 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…

Canllaw Defnyddiwr Strategaeth Technoleg Gwybodaeth FDA

Tachwedd 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 Rhwydwaith Cyfarwyddiadau Arbenigwyr

Hydref 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…

Canllaw Defnyddiwr Gwybodaeth Meddyginiaeth Cleifion FDA

Hydref 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…

Llawlyfr Perchennog Systemau Cadw Cofnodion Electronig FDA CDER

Hydref 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…

MAPPA FDA 6702.1 Parthview o Lawlyfr Perchennog Strategaeth Gwerthuso a Lliniaru Risg

Hydref 19, 2024

MAPPA FDA 6702.1 Parthview 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…

Canllaw Defnyddiwr Porth NextGen FDA CDER

Hydref 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…

GUDID User Manual: How to Unlock and Edit Device Records in the FDA Database

Llawlyfr Defnyddiwr

User manual providing instructions on how to unlock and edit device records within the FDA's Global Unique Device Identification Database (GUDID), covering the unlock process, editing procedures, and important considerations…

FDA Food Facility Registration User Guide: Additional Capabilities

Canllaw Defnyddiwr

A comprehensive user guide from the U.S. Food & Drug Administration (FDA) detailing additional capabilities within the Food Facility Registration (FFR) system, including managing registrations, cancellations, and searching facility information.

Canllaw Atodol FDA ACE: Canllaw Cyfeirio Cyflym y Diwydiant v2.5.3

Tywysydd

Canllaw cyfeirio cyflym cynhwysfawr ar gyfer mewnforwyr a filers on reporting information to the FDA for regulated products entering the United States via the Automated Commercial Environment (ACE) system, covering…

Canllaw Llawlyfr Staff FDA 1121.934: Sefydliadau a Swyddogaethau Labordy Bwyd a Bwyd Anifeiliaid y Gogledd-ddwyrain

Staff Manual

Official FDA Staff Manual Guide 1121.934 detailing the organizational structure and functional responsibilities of the Northeast Food and Feed Laboratory (DCIFCD) and its branches, including Chemistry Branch 1, Chemistry Branch…

Aseptic Processing of Biological Products: Current Regulatory Issues and Manufacturing Challenges

Dogfen Ganllawiau

Guidance on current regulatory issues and common deficiencies in aseptic processing of biological products, covering laws, regulations, BLA content, process validation, sterilizing filtration, post-reconstitution/dilution storage, and container closure integrity. Presented…

Llawlyfr Dadansoddol Bacteriolegol Pennod 23: Dulliau ar gyfer Cosmetigau - FDA

Llawlyfr

Canllaw cynhwysfawr yn manylu ar ddulliau profi microbiolegol ar gyfer cynhyrchion cosmetig, gan gynnwysampparatoi, cyfrif, adnabod microbau, a phrofi effeithiolrwydd cadwolion, fel y'u cyhoeddwyd gan Weinyddiaeth Bwyd a Chyffuriau'r Unol Daleithiau (FDA).

Canllaw FDA ESG NextGen AS2 ar gyfer Defnyddwyr y Diwydiant - Fersiwn 2.0

Tywysydd

Canllaw swyddogol i ddefnyddwyr y diwydiant ar gyflwyno data drwy AS2 i system NextGen Porth Cyflwyno Electronig (ESG) yr FDA. Yn cwmpasu ffurfweddu, y broses gyflwyno, a datrys problemau.

Gwneud i ACE Weithio i Chi: Canllaw Mewnforio Cynhyrchion a Reoleiddir gan yr FDA

Tywysydd

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,…

Cyflwyniadau ANDA: Canllawiau Cynnwys a Fformat ar gyfer y Diwydiant

Arweiniad

Canllawiau FDA yr Unol Daleithiau ar gyfer y diwydiant ar Geisiadau Cyffuriau Newydd Byr (ANDAs), yn manylu ar ofynion cynnwys a fformat gan ddefnyddio strwythur y Ddogfen Dechnegol Gyffredin (CTD) ar gyfer cyflwyniadau cynhyrchion fferyllol.

FDA Guide to Documents, Change Control, and Records Management

Tywysydd

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…

Deall y System Ansawdd Fferyllol (PQS) ar gyfer Arolygiadau FDA

Tywysydd

Mae drosoddview 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…

Rhaglen Cydymffurfiaeth FDA 7356.002: Arolygiadau Gweithgynhyrchu Cyffuriau

Compliance Program

Mae'r ddogfen hon yn manylu ar Raglen Gydymffurfiaeth 7356.002 Gweinyddiaeth Bwyd a Chyffuriau'r Unol Daleithiau, gan ddarparu canllawiau ar arolygiadau gweithgynhyrchu cyffuriau, sicrhau ansawdd, gofynion CGMP, a goruchwyliaeth reoleiddiol ar gyfer cynhyrchion fferyllol.