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Manual & Panduan Pengguna FDA

Pentadbiran Makanan dan Ubat-ubatan AS (FDA) ialah agensi persekutuan yang bertanggungjawab melindungi kesihatan awam dengan mengawal selia makanan, ubat-ubatan, peralatan perubatan, kosmetik dan banyak lagi.

Petua: sertakan nombor model penuh yang dicetak pada label FDA anda untuk padanan terbaik.

Sokongan FDA

Tapak rasmi: https://www.fda.gov/
Sokongan umum: https://www.fda.gov/about-fda/contact-fda
Telefon sokongan: 1-888-463-6332 — Isnin-Jumaat 8:00 pagi - 4:30 petang ET
E-mel sokongan: webmail@oc.fda.gov
Borang hubungan: Hubungi sokongan pengilang

Manual FDA

Manual terkini daripada manuals+ dipilih susun untuk jenama ini.

Manual Pemilik Krim Muka Biasa FDA Mens

24 Januari 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,…

Manual Pemilik Krim Anti Penuaan FDA

24 Januari 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 Panduan Pengguna

2 Januari 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 Menyalakan Panduan Pengguna Laluan Pembangunan

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…

Panduan Pengguna Strategi Teknologi Maklumat FDA

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 Arahan Rangkaian Pakar

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…

Panduan Pengguna Maklumat Ubat Pesakit FDA

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…

Manual Pemilik Sistem Penyimpanan Rekod Elektronik FDA CDER

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 Review Manual Pemilik Penilaian Risiko dan Strategi Mitigasi

19 Oktober 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…

Panduan Pengguna Portal NextGen FDA CDER

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…

Menjadikan ACE Berfungsi untuk Anda: Mengimport Panduan Produk Dikawal FDA

Panduan

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,…

Penyerahan ANDA: Panduan Kandungan dan Format untuk Industri

Bimbingan

Panduan FDA AS untuk industri tentang Aplikasi Dadah Baharu Singkatan (ANDA), memperincikan kandungan dan keperluan format menggunakan struktur Dokumen Teknikal Biasa (CTD) untuk penyerahan produk farmaseutikal.

FDA Guide to Documents, Change Control, and Records Management

Panduan

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…

Memahami Sistem Kualiti Farmaseutikal (PQS) untuk Pemeriksaan FDA

Panduan

Berakhirview 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…

Program Pematuhan FDA 7356.002: Pemeriksaan Pengilangan Dadah

Compliance Program

Dokumen ini memperincikan Program Pematuhan Pentadbiran Makanan dan Ubat AS 7356.002, memberikan panduan tentang pemeriksaan pembuatan ubat, jaminan kualiti, keperluan CGMP dan pengawasan kawal selia untuk produk farmaseutikal.

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: Interdisipliner Review Pasukan untuk Dasar dan Prosedur Kajian QT

Manual

Manual rasmi yang memperincikan dasar dan prosedur untuk Pusat Penilaian dan Penyelidikan Dadah (CDER) Antara Disiplinview 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

Manual Kakitangan

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.

Spesifikasi Pelaksanaan Serantau FDA untuk ICH E2B(R3) untuk Penyerahan Laporan Keselamatan Elektronik

Spesifikasi Teknikal

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

Panduan

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.…

REMS Opioid Analgesik FDA: Panduan untuk Masyarakat Profesional mengenai Penetapan dan Pelupusan yang Selamat

Bimbingan

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…

Rangka Tindakan Pendidikan REMS Opioid Opioid Analgesik untuk Penyedia Penjagaan Kesihatan

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…