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Manual & Pituduh Pangguna 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.

Tip: kalebet nomer modél lengkep anu dicitak dina labél FDA anjeun pikeun cocog anu pangsaéna.

Dukungan FDA

Situs resmi: https://www.fda.gov/
rojongan umum: https://www.fda.gov/about-fda/contact-fda
Telepon rojongan: 1-888-463-6332 — Mon-Jum 8:00am - 4:30pm AND
email rojongan: webmail@oc.fda.gov
Formulir kontak: Kontak rojongan produsén

Manual FDA

manual panganyarna ti manuals+ curated pikeun merek ieu.

Manual Pamilik krim raray polos FDA Mens

24 Januari 2025

Spésifikasi Krim Beungeut Biasa FDA Pikeun Lalaki Jenis Produk: HUMAN OTC DRUG TOPICAL Kode Barang (Sumber): NDC:84522-526 Bahan Aktif: Asam salisilat 2% Bahan Teu Aktif: Kopolimer Akrilat, Etil asetat, NIACINAMIDA, KLORFENESIN, GLISERIN,…

Manual Pamilik Krim Anti Aging FDA

24 Januari 2025

Spésifikasi Produk Krim Anti Aging FDA Ngaran Produk: Krim Anti Aging Jenis Produk: Krim Topikal Bahan Aktif: Niacinamide Kakuatan: 5 g dina 100 g Bahan Teu Aktif: Minyak Wijén, Gliserin, Klorfenesin, Palmitoyl…

FDA Meta Quest 3 Campuran kanyataanana Headsét 128 GB Guide pamaké

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 Nyaangan Panungtun Pamaké Jalur Pangembangan

27 Nopémber 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…

Pituduh Pamaké Stratégi Téhnologi Émbaran FDA

13 Nopémber 2024

Strategi Téknologi Informasi FDA pikeun Taun Fiskal 2024 dugi ka 2027 Pesen ti CIO Abdi bingah ngabagikeun publikasi taunan kami ngeunaan Strategi IT FDA pikeun TA 2024…

FDA 6001.2 Jaringan Para Ahli Parentah

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…

Pituduh Pamaké Émbaran Pangobatan Pasien 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 Pamilik Sistem Ngajaga Rékam Éléktronik 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 ulangview Buku Panduan Pamilik Evaluasi Risiko sareng Strategi Mitigasi

19 Oktober 2024

FDA MAPP 6702.1 ulangview Spésifikasi Strategi Evaluasi sareng Mitigasi Risiko Ngaran Produk: Manual Kawijakan sareng Prosedur Pusat Evaluasi sareng Panalungtikan Narkoba (MAPP 6702.1) Kantor Asal: Kantor…

FDA CDER NextGen Portal Pituduh Pamaké

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…

Nyieun ACE Gawé pikeun Anjeun: Importing FDA Regulasi Produk Guide

Pituduh

Pituduh lengkep ti Badan Pengawas Obat jeung Kadaharan AS (FDA) anu ngajelaskeun kumaha cara ngagunakeun Lingkungan Komersial Otomatis (ACE) sacara efektif pikeun ngimpor produk anu diatur ku FDA, anu ngawengku prosés konci, masalah umum,…

Kiriman ANDA: Eusi sareng Format Pitunjuk pikeun Industri

Pituduh

Pitunjuk FDA AS pikeun industri ngeunaan Aplikasi Narkoba Anyar (ANDAs), ngajéntrékeun eusi sareng syarat format nganggo struktur Dokumén Téknis Umum (CTD) pikeun kiriman produk farmasi.

FDA Guide to Documents, Change Control, and Records Management

Pituduh

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…

Ngartos Sistem Kualitas Farmasi (PQS) pikeun Inspeksi FDA

Pituduh

Hiji leuwihview 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 minuhan FDA 7356.002: Inspections Manufaktur Narkoba

Compliance Program

Dokumén ieu ngajéntrékeun Program Kepatuhan Administrasi Pangan sareng Narkoba AS 7356.002, nyayogikeun pitunjuk ngeunaan pamariksaan pabrik obat, jaminan kualitas, syarat CGMP, sareng pangawasan pangaturan pikeun produk farmasi.

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: Interdisciplinary Review Tim pikeun Sarat jeung Kaayaan Studi QT sarta Prosedur

Manual

Manual resmi ngajéntrékeun kabijakan sareng prosedur pikeun Pusat Evaluasi sareng Panaliti Narkoba (CDER) Interdisciplinary Review Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

Pusat FDA pikeun Produk Roko Kantor Diréktur Pusat: Organisasi sareng Fungsi

Manual Staf

Pituduh manual staf resmi anu ngajéntrékeun struktur organisasi sareng fungsi konci Kantor Diréktur Pusat (DCFA) dina Pusat Produk Roko Administrasi Pangan sareng Narkoba AS.

FDA Regional Implementation Specifications for ICH E2B(R3) for Electronic Safety Report Submissions

Spésifikasi Téknis

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

Pituduh

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 Analgesic REMS: Pitunjuk pikeun Masyarakat Profesional ngeunaan Resep sareng Pembuangan Aman

Pituduh

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 Opioid Analgesic REMS Atikan Blueprint pikeun Panyadia Podomoro

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…