Manuais e guias do usuário da 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.
Sobre os manuais da FDA em Manuals.plus
O U.S. Food and Drug Administration (FDA) is a federal agency of the Department of Health and Human Services. It is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed, and veterinary products.
This directory serves as a resource for user manuals related to FDA systems (such as the Electronic Submission Gateway), regulatory guidelines, and official prescribing information (package inserts) for FDA-approved medical products.
Manuais da FDA
Manuais mais recentes de manuals+ Selecionado especialmente para esta marca.
FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Instructions
Guia do Usuário da Injeção de Blenrep Belantamab Mafodotin BLMF (FDA 761440s000lbl)
Guia do usuário do aplicativo FDA ESG NEXTGEN
Guia do usuário de última geração do FDA AS2 Electronic Submission Gateway
Instruções do método suplementar FDA V-8.F para folhas de louro inteiras
Instruções do FDA US Food and Drug Administration Center
Instruções FDA NDA 215014-S-008 Empaveli REMS
Guia do usuário do aplicativo FDA Authenticator
Manual do proprietário do creme super retinol da FDA para homens
Bioanalytical Method Validation for Biomarkers: FDA Guidance for Industry
FDA CDER MAPP 6025.4: Good Review Practice - Refuse To File Política
Write It Right: Recommendations for Developing User Instruction Manuals for Home Health Care Medical Devices
Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition
FDA Forms Management Policy and Procedures
Elemental Analysis Manual for Food: ICP-MS Method for Trace Elements
Orientações para submissões de notificação pré-comercialização de indicadores biológicos [510(k)]
Manual do Usuário do GUDID: Como desbloquear e editar registros de dispositivos no banco de dados da FDA
Guia do Usuário para Registro de Instalações Alimentares da FDA: Recursos Adicionais
Guia Suplementar ACE da FDA: Guia de Referência Rápida para a Indústria v2.5.3
Manual do Pessoal da FDA Guia 1121.934: Organizações e Funções de Laboratórios de Alimentos e Rações do Nordeste
Processamento asséptico de produtos biológicos: questões regulatórias atuais e desafios de fabricação
FDA support FAQ
Perguntas frequentes sobre manuais, registro e suporte para esta marca.
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What is the FDA Electronic Submission Gateway (ESG)?
The FDA ESG is an agency-wide solution for accepting electronic regulatory submissions. It enables the secure submission of regulatory information for review by the agency.
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How do I report a problem with a medical device or drug?
You can report adverse events or quality problems with FDA-regulated products through the MedWatch program online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
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Where can I find prescribing information for FDA-approved drugs?
Prescribing information (package inserts) is available on the FDA website via the Drugs@FDA database. Many of these documents are also archived here for easy reference.
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Does the FDA provide warranties for medical products?
No, the FDA regulates the safety and efficacy of products but does not manufacture or warranty them. Warranty claims should be directed to the specific product manufacturer.