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FDA Manuals & User Guides

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.

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FDA manuals

Najnoviji priručnici od manuals+ odabrano za ovaj brend.

Priručnik za upotrebu FDA obične muške kreme za lice

24. siječnja 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,…

Upute za upotrebu FDA kreme protiv starenja

24. siječnja 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 korisnički priručnik

2. siječnja 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 Korisnički priručnik za osvjetljavanje razvojnog puta

27. studenog 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…

Korisnički priručnik za strategiju informacijske tehnologije FDA

13. studenog 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 Upute mreže stručnjaka

28. listopada 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…

Korisnički priručnik s informacijama o lijekovima za pacijente FDA

23. listopada 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…

Vlasnički priručnik FDA CDER elektroničkih sustava za vođenje zapisa

19. listopada 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 Vlasničkog priručnika za procjenu rizika i strategiju ublažavanja

19. listopada 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…

FDA CDER NextGen Portal Korisnički priručnik

19. listopada 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…

Making ACE Work for You: Importing FDA Regulated Products Guide

Vodič

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,…

ANDA prijave: Smjernice za sadržaj i format za industriju

vođenje

Smjernice američke FDA za industriju o skraćenim zahtjevima za nove lijekove (ANDA), u kojima se detaljno opisuju zahtjevi za sadržaj i format korištenjem strukture Zajedničkog tehničkog dokumenta (CTD) za podnošenje farmaceutskih proizvoda.

FDA Guide to Documents, Change Control, and Records Management

Vodič

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…

Razumijevanje farmaceutskog sustava kvalitete (PQS) za FDA inspekcije

Vodič

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…

Program usklađenosti FDA 7356.002: Inspekcije proizvodnje lijekova

Compliance Program

Ovaj dokument detaljno opisuje Program usklađenosti 7356.002 Američke agencije za hranu i lijekove (FDA), pružajući smjernice o inspekcijama proizvodnje lijekova, osiguranju kvalitete, zahtjevima CGMP-a i regulatornom nadzoru nad farmaceutskim proizvodima.

FDA Manuals & User Guides

FDA manuals

Priručnik za upotrebu FDA obične muške kreme za lice

Upute za upotrebu FDA kreme protiv starenja

FDA Meta Quest 3 Mixed Reality Headset 128 GB korisnički priručnik

FDA DTP-1 Korisnički priručnik za osvjetljavanje razvojnog puta

Korisnički priručnik za strategiju informacijske tehnologije FDA

FDA 6001.2 Upute mreže stručnjaka

Korisnički priručnik s informacijama o lijekovima za pacijente FDA

Vlasnički priručnik FDA CDER elektroničkih sustava za vođenje zapisa

FDA MAPP 6702.1 Review Vlasničkog priručnika za procjenu rizika i strategiju ublažavanja

FDA CDER NextGen Portal Korisnički priručnik

Making ACE Work for You: Importing FDA Regulated Products Guide

ANDA prijave: Smjernice za sadržaj i format za industriju

FDA Guide to Documents, Change Control, and Records Management

Razumijevanje farmaceutskog sustava kvalitete (PQS) za FDA inspekcije

Program usklađenosti FDA 7356.002: Inspekcije proizvodnje lijekova

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

CDER MAPP 6020.14: Interdisciplinarni review Politika i postupci Tima za studije kvantitativnog razvoja

Centar FDA za duhanske proizvode Ured ravnatelja Centra: Organizacije i funkcije

Regionalne provedbene specifikacije FDA-e za ICH E2B(R3) za podnošenje elektroničkih izvješća o sigurnosti

Guide for Preparing FDA Annual Reports on Laser Radiation Safety Testing

FDA opioidni analgetici REMS: Smjernice za profesionalna društva o sigurnom propisivanju i zbrinjavanju

FDA-in obrazovni nacrt za REMS opioidne analgetike za zdravstvene djelatnike