FDA Manuals & User Guides

FDA Meta Quest 3 Mixed Reality Headset 128 GB brugervejledning

2. januar 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 Brugervejledning

27. november 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

13. november 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 Instruktioner

28. oktober 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 Medicin Information User Guide

23. oktober 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 ejermanual

19. oktober 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 vedrview of Risk Evaluation and Mitigation Strategy Owner's Manual

19. oktober 2024

FDA MAPP 6702.1 vedrview 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 brugervejledning

19. oktober 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 injektionsinstruktioner

10. oktober 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-testinstruktioner

30. september 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 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…

Forståelse af det farmaceutiske kvalitetssystem (PQS) til FDA-inspektioner

Guide

En 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-overholdelsesprogram 7356.002: Inspektioner af lægemiddelproduktion

Compliance Program

Dette dokument beskriver den amerikanske fødevare- og lægemiddelstyrelses (FDA) compliance-program 7356.002, der giver vejledning om inspektioner af lægemiddelproduktion, kvalitetssikring, CGMP-krav og lovgivningsmæssigt tilsyn med farmaceutiske produkter.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

manuel

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: Tværfaglig vedrview Team for QT-studier Politik og Procedurer

Manuel

Officiel manual med detaljerede retningslinjer og procedurer for Center for Drug Evaluation and Research (CDER) Interdisciplinary Review Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

FDA Center for Tobaksvarer Centerdirektørens kontor: Organisationer og funktioner

Staff Manual

Officiel personalemanual, der beskriver den organisatoriske struktur og nøglefunktioner for Office of the Center Director (DCFA) inden for den amerikanske fødevare- og lægemiddelstyrelses Center for Tobacco Products.

FDA's regionale implementeringsspecifikationer for ICH E2B(R3) til indsendelse af elektroniske sikkerhedsrapporter

Teknisk specifikation

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 Analgeticum REMS: Vejledning til professionelle selskaber om sikker ordination og bortskaffelse

Vejledning

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's uddannelsesplan for opioid smertestillende REMS til sundhedspersonale

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's lov om modernisering af fødevaresikkerhed (FSMA) er slutview

Faktaark

En 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

vejledning

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…