Manwali u Gwidi għall-Utent tal-FDA

Manwal tas-sid tal-FDA Mens Plain Face Cream

24 ta’ Jannar, 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,…

Manwal tas-Sid tal-Krema Kontra l-Aging tal-FDA

24 ta’ Jannar, 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 Gwida għall-Utent

2 ta’ Jannar, 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 Iddawwal il-Gwida tal-Utent tal-Mogħdija tal-Iżvilupp

27 ta’ Novembru, 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…

Gwida għall-Utent tal-Istrateġija tat-Teknoloġija tal-Informazzjoni tal-FDA

13 ta’ Novembru, 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…

Istruzzjonijiet tan-Netwerk ta' Esperti tal-FDA 6001.2

28 ta’ Ottubru, 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…

Gwida għall-Utent ta' Informazzjoni dwar Medikazzjoni tal-Pazjent tal-FDA

23 ta’ Ottubru, 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…

Manwal tas-Sid tas-Sistemi ta' Żamma ta' Rekords Elettroniċi tal-FDA CDER

19 ta’ Ottubru, 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 tal-Manwal tas-Sid ta' l-Istrateġija ta' Evalwazzjoni tar-Riskju u ta' Mitigazzjoni

19 ta’ Ottubru, 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…

Gwida għall-Utent tal-Portal NextGen tal-FDA CDER

19 ta’ Ottubru, 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…

Nagħmlu l-ACE Jaħdem Għalik: Gwida għall-Importazzjoni ta' Prodotti Regolati mill-FDA

Gwida

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,…

Sottomissjonijiet tal-ANDA: Gwida dwar il-Kontenut u l-Format għall-Industrija

Gwida

Gwida tal-FDA tal-Istati Uniti għall-industrija dwar Applikazzjonijiet Abbrevjati għal Mediċini Ġodda (ANDAs), li tiddettalja r-rekwiżiti tal-kontenut u l-format bl-użu tal-istruttura tad-Dokument Tekniku Komuni (CTD) għas-sottomissjonijiet ta' prodotti farmaċewtiċi.

FDA Guide to Documents, Change Control, and Records Management

Gwida

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…

Nifhmu s-Sistema ta' Kwalità Farmaċewtika (PQS) għall-Ispezzjonijiet tal-FDA

Gwida

An fuqview 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…

Programm ta' Konformità tal-FDA 7356.002: Spezzjonijiet tal-Manifattura tal-Mediċini

Compliance Program

Dan id-dokument jagħti dettalji dwar il-Programm ta' Konformità 7356.002 tal-Amministrazzjoni tal-Ikel u d-Droga tal-Istati Uniti, li jipprovdi gwida dwar l-ispezzjonijiet tal-manifattura tad-drogi, l-assigurazzjoni tal-kwalità, ir-rekwiżiti tas-CGMP, u s-sorveljanza regolatorja għall-prodotti farmaċewtiċi.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

manwal

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: Interdixxiplinari Review Politika u Proċeduri tat-Tim għall-Istudji QT

Manwal

Manwal uffiċjali li jiddettalja l-politiki u l-proċeduri għaċ-Ċentru għall-Evalwazzjoni u r-Riċerka dwar il-Mediċini (CDER) Interdixxiplinariview Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

Ċentru tal-FDA għall-Prodotti tat-Tabakk Uffiċċju tad-Direttur taċ-Ċentru: Organizzazzjonijiet u Funzjonijiet

Staff Manual

Gwida uffiċjali tal-manwal tal-persunal li tiddeskrivi l-istruttura organizzattiva u l-funzjonijiet ewlenin tal-Uffiċċju tad-Direttur taċ-Ċentru (DCFA) fi ħdan iċ-Ċentru għall-Prodotti tat-Tabakk tal-Amministrazzjoni tal-Ikel u d-Droga tal-Istati Uniti.

Speċifikazzjonijiet ta' Implimentazzjoni Reġjonali tal-FDA għall-ICH E2B(R3) għas-Sottomissjonijiet ta' Rapporti ta' Sigurtà Elettroniċi

Speċifikazzjoni Teknika

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

Gwida

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: Gwida għas-Soċjetajiet Professjonali dwar il-Preskrizzjoni u r-Rimi Sikuri

Gwida

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…

Pjan Edukattiv tal-FDA dwar l-Analġeżiċi REMS dwar l-Opjojdi għall-Fornituri tal-Kura tas-Saħħa

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…