FDA vadovai ir naudotojo vadovai
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.
About FDA manuals on Manuals.plus
The 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.
FDA vadovai
Naujausi vadovai iš manuals+ šiam prekės ženklui kuruota.
FDA Sotyktu Deucravacitinib Tablets Owner’s Manual
FDA Anzupgo Delgocitinib Cream Owner’s Manual
FDA Alectinib Capsules Owner’s Manual
FDA 2BVLC-PREX Laser Engraver Instruction Manual
FDA Pifeltro Doravirino tabletės ŽIV infekcijai gydyti naudotojo vadovas
FDA natalizumabo-sztn Tyruko pirmasis ir vienintelis išsėtinės sklerozės biologiškai panašus vaistas instrukcijos
FDA 761440s000lbl Blenrep Belantamabo Mafodotino Blmf injekcijos naudotojo vadovas
FDA ESG NEXTGEN programos vartotojo vadovas
FDA AS2 elektroninio pateikimo šliuzas Next Gen vartotojo vadovas
Opioid Analgesic REMS Assessment Plan (November 25, 2025)
General Instructions for Form FDA 3500A MedWatch
MAPP 5015.14: Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs
FDA CDER Direct: Electronic Submissions Portal for Product Listing and Registration
CFSAN Online Submission Module (COSM) Quick Start Guide
FDA ACE Error Guide: Understanding and Resolving Entry Rejection Messages
Proprietary Names: Center for Veterinary Medicine Program Policy and Procedures Manual
Bioanalytical Method Validation for Biomarkers: FDA Guidance for Industry
FDA CDER MAPP 6025.4: Good Review Practice - Refuse To File politika
Write It Right: Recommendations for Developing User Instruction Manuals for Home Health Care Medical Devices
Žuvų ir žuvininkystės produktų pavojų ir kontrolės gairės. Ketvirtasis leidimas
FDA formų valdymo politika ir procedūros
FDA video guides
Peržiūrėkite šio prekės ženklo vaizdo įrašus apie sąranką, diegimą ir trikčių šalinimą.
CDRH eSubmitter Basics: FDA Electronic Submissions Software Tutorial
CDRH eSubmitter eCopy Video Tutorial: Creating a New Non-Volume Based Submission
CDRH eSubmitter eCopy Video Tutorial: Creating a New eSubmitter eCopy Submission, Volume Based
CDRH eSubmitter eCopy Tutorial: Adding Non-PDF Files to Submissions
CDRH eSubmitter eCopy Tutorial: Revising a Packaged Submission for FDA
FDA support FAQ
Dažniausiai užduodami klausimai apie šio prekės ženklo vadovus, registraciją ir palaikymą.
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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.