FDA käsiraamatud ja kasutusjuhendid

FDA Pifeltro Doravirine Tablet of Hiv Infection User Manual

2. jaanuar 2026

FDA Pifeltro Doravirine Tablet of Hiv Infection INDICATIONS AND USAGE PIFELTRO® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment…

Kaubamärk: FDA

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Instructions

1. jaanuar 2026

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Specifications Product Name: TYRUKO Indication: Integrin receptor antagonist for the treatment of Multiple Sclerosis (MS) Dosage Form: Injection Strength: 300 mg/15 mL (20 mg/mL) solution IMPORTANT SAFETY INSORMATION WARNING: PROGRESSIVE MULTIFOCAL…

Kaubamärk: FDA

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection User Guide

25. detsember 2025

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection Specifications Product Name: BLENREP Generic Name: Belantamab Mafodotin-blmf Administration: Intravenous Use Approval Year: 2020 Dosage Form: Lyophilized powder for injection Strength: 70 mg Contraindications There are no contraindications listed for BLENREP use. HIGHLIGHTS…

Kaubamärk: FDA

FDA kiidab heaks Abbott TriClip TEER-süsteemi kasutusjuhendi

11. november 2025

FDA approves Abbott TriClip TEER System This Patient guide is for those who have severe tricuspid regurgitation (TR) but continue to have symptoms despite being on heart failure medication. Be sure to ask your Heart Team to explain all your…

Kaubamärk: Abbott

FDA ESG NEXTGEN rakenduse kasutusjuhend

5. aprill 2025

FDA elektroonilise esitamise värav (ESG) NextGen API juhend FDA elektroonilise esitamise värav (ESG) NextGen API juhend Rakendusprogrammi liides Versioon 1.0 Märts 2025 1. Sissejuhatus See dokument annab esitamise juhised files and folders through Application Programming Interfaces (APIs) with…

Kaubamärk: FDA

FDA AS2 elektroonilise esitamise lüüsi järgmise põlvkonna kasutusjuhend

5. aprill 2025

FDA AS2 Electronic Submission Gateway Next Gen Product Usage Instructions This guide is intended for industry participants who want to utilize AS2 to submit regulatory information to the FDA. The audience includes current AS2 submitters and user technical support resources.…

Kaubamärk: FDA

FDA V-8.F täiendav meetod tervete loorberilehtede juhiste jaoks

7. märts 2025

Macroanalytical Procedures Manual (MPM) V-8. Spices, Condiments, Flavors, and Crude Drugs F. Supplemental Method for Whole Bay Leaves February 2025 Editor (s): Hans Loechelt-Yoshioka Co-editor(s): Amy Barnes, Richard Haynos (Retired) F. Supplemental Method for Whole Bay Leaves Scope This method…

Kaubamärk: FDA

FDA USA toidu- ja ravimiameti juhised

6. märts 2025

U.S. Food and Drug Administration Center for Devices and Radiological Health Digital Health Advisory Committee (DHAC) Meeting on the topic "Total Product Lifecycle Considerations for Generative AI-Enabled Devices" Summary Minutes for Day 1 - November 20, 2024 Introduction On November…

Kaubamärk: FDA

FDA NDA 215014-S-008 Empaveli REMS juhised

4. veebruar 2025

FDA NDA 215014-S-008 Empaveli REMSi tootekasutusjuhised Programmi rakendamine ja toimingud REMS-i programmi rakendamine (ainult 6-kuulised ja 1-aastased hinnangud): Empaveli esimese kaubandusliku levitamise kuupäev. Empaveli REMS-i käivitamise kuupäev. Kuupäev, millal REMS Website became live and…

Kaubamärk: FDA

FDA Authenticator Appi kasutusjuhend

30. jaanuar 2025

Multi-factor Authentication User Guide Authenticator App Multi-factor Authentication (MFA) is a security mechanism to build stronger authentication into the LearnED LMS standard login process. Non-FDA Users who are required to log in with MFA must use a mobile device, such…

Kaubamärk: FDA

Proprietary Names: Center for Veterinary Medicine Program Policy and Procedures Manual

Policy and Procedures Manual • March 11, 2026

This document outlines the policies and procedures for identifying, formatting, and using proprietary names within the Center for Veterinary Medicine (CVM) for animal drug evaluations, including administrative processes and documentation guidelines.

Kaubamärk: FDA

Bioanalytical Method Validation for Biomarkers: FDA Guidance for Industry

guide • February 20, 2026

Guidance from the U.S. Food and Drug Administration (FDA) on validating bioanalytical methods for biomarkers in drug development. Covers scope, purpose, and key validation characteristics for nonclinical and clinical studies.

Kaubamärk: FDA

FDA CDER MAPP 6025.4: Good Review Practice - Refuse To File poliitika

Policy Manual • February 17, 2026

This document outlines the policies, responsibilities, and procedures for the FDA's Center for Drug Evaluation and Research (CDER) Office of New Drugs staff regarding the 'Refuse To File' (RTF) process for New Drug Applications (NDAs) and Biologics License Applications (BLAs).

Kaubamärk: FDA

Write It Right: Recommendations for Developing User Instruction Manuals for Home Health Care Medical Devices

Guidance Document • January 4, 2026

Guidance from the U.S. Food and Drug Administration (FDA) on creating clear, accessible, and effective user instruction manuals for medical devices intended for home health care. This document assists manufacturers in planning, writing, designing, and testing manuals to ensure safe and effective…

Kaubamärk: FDA

Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition

Guidance • December 31, 2025

Guidance for the fish and fishery products industry on developing HACCP plans, identifying hazards (biological, chemical, physical), and implementing control strategies for seafood safety, covering pathogens, toxins, allergens, and contaminants.

Kaubamärk: FDA

FDA Forms Management Policy and Procedures

Staff Manual Guide • December 24, 2025

Official policy and procedural guide from the Food and Drug Administration (FDA) detailing the development, management, and lifecycle of agency forms, including printed and electronic formats, ensuring compliance and efficiency.

Kaubamärk: FDA

Elemental Analysis Manual for Food: ICP-MS Method for Trace Elements

Laboratory Method • December 24, 2025

Detailed laboratory method by the U.S. FDA for determining trace elemental concentrations in food using ICP-MS and Microwave Assisted Digestion. Covers Arsenic, Cadmium, Chromium, Lead, Mercury, and other key elements.

Kaubamärk: FDA

Guidance for Biological Indicator (BI) Premarket Notification [510(k)] Submissions

Guidance Document • December 22, 2025

FDA guidance document for industry on preparing Premarket Notification (510(k)) submissions for Biological Indicators (BIs) used in healthcare sterilization monitoring. Covers device description, performance characteristics, and regulatory requirements.

Kaubamärk: FDA

GUDID User Manual: How to Unlock and Edit Device Records in the FDA Database

Kasutusjuhend • 29. oktoober 2025

User manual providing instructions on how to unlock and edit device records within the FDA's Global Unique Device Identification Database (GUDID), covering the unlock process, editing procedures, and important considerations for labelers.

Kaubamärk: FDA

FDA Food Facility Registration User Guide: Additional Capabilities

Kasutusjuhend • 14. oktoober 2025

A comprehensive user guide from the U.S. Food & Drug Administration (FDA) detailing additional capabilities within the Food Facility Registration (FFR) system, including managing registrations, cancellations, and searching facility information.

Kaubamärk: FDA

FDA ACE lisajuhend: tööstusharu kiirjuhend v2.5.3

Juhend • 3. oktoober 2025

Põhjalik kiirjuhend importijatele ja filers teabe esitamise kohta FDA-le reguleeritud toodete kohta, mis sisenevad Ameerika Ühendriikidesse automatiseeritud kaubanduskeskkonna (ACE) süsteemi kaudu, hõlmates erinevaid tootekategooriaid, nagu bioloogilised ravimid, ravimid, toit, meditsiiniseadmed ja tubakas.

Kaubamärk: FDA

FDA personali käsiraamat 1121.934: Kirdeosa toidu- ja söödalabori organisatsioonid ja funktsioonid

Staff Manual • September 21, 2025

FDA ametlik personali käsiraamat 1121.934, milles on üksikasjalikult kirjeldatud Kirde Toidu- ja Söödalabori (DCIFCD) ja selle harude, sealhulgas keemiaharu 1, keemiaharu 2 ja mikrobioloogiateaduste haru organisatsioonilist struktuuri ja funktsionaalseid kohustusi.

Kaubamärk: FDA