Manwali u Gwidi għall-Utent tal-FDA

Istruzzjonijiet ta 'l-injezzjoni ta' Midazolam FDA

10 ta’ Ottubru, 2024

FDA Midazolam Injection Product Information Specifications Product Name: Midazolam Autoinjector Manufacturer: Rafa Laboratories, Ltd. Address: 3 Zeev Lev, Har Hotzvim Jerusalem, 9777515 Israel Revision Date: 11/2023 Reference ID: 5026561 Product…

FDA K240280 Nano Check RSV Test Istruzzjonijiet

30 ta’ Settembru, 2024

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) Number  K240280 B Applicant  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information Product Code(s) Classification Regulation Section…

AID E2B(R3) Trażmissjoni Elettronika ta' Rapporti ta' Sigurtà ta' Każ Individwali Gwida għall-Utent

15 ta’ Settembru, 2024

FDA E2B(R3) Electronic Transmission of Individual Case Safety Reports Product Information Specifications: Product Name: FDA Regional Implementation Guide for E2B(R3) Electronic Transmission Compatibility: Drug and Biological Products Version: 3.1 Published…

FDA h:2250.1 Istruzzjonijiet tal-Kwartieri Ġenerali tal-Posta bil-kejl

23 ta’ Awwissu, 2024

FDA h2250.1 Metered Mail Għan Din il-Gwida tistabbilixxi rekwiżiti għall-kejl tal-posta amministrattiva ħierġa f'postijiet tal-Kwartieri Ġenerali sabiex tħallas bil-quddiem USPS postage costs. Background In order…

Gwida għall-Utent tal-Modulu ta' Sottomissjoni onlajn tal-FDA CFSAN

15 ta’ Awwissu, 2024

FDA CFSAN Online Submission Module INTRODUCTION This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and illustrate how to assemble an OFAS Regulatory submission. COSM presents…

Gwida għall-Utent tal-Modulu ta' Sottomissjoni tal-FDA CFSAN

15 ta’ Awwissu, 2024

FDA CFSAN Submission Module Product Information Specifications Product Name: CFSAN Online Submission Module (COSM) Availability: 24 hours, 7 days a week Developed for: Transmitting submissions to FDA's CFSAN Product Usage…

FDA 2004-N-0451 Istruzzjonijiet dwar l-Ikel u d-Droga

31 ta’ Lulju, 2024

FDA 2004-N-0451 Food and Drug Specifications Product Name: Food and Drug Administration Modernization Act of 1997 Recognition List Number: 062 Agency: Food and Drug Administration, HHS Product Usage Instructions Registration…

L-FDA tindirizza informazzjoni żbaljata dwar Apparat Mediku u Istruzzjonijiet dwar Drogi bi Preskrizzjoni

9 ta’ Lulju, 2024

FDA Addressing Misinformation About Medical Devices and Prescription Drugs Product Information Specifications Manufacturer: U.S. Department of Health and Human Services Food and Drug Administration Centers Covered: CDER, CBER, CDRH, CVM,…

Istruzzjonijiet tal-Pillola tas-Sospensjoni Orali tal-FDA Viramune

6 ta’ Lulju, 2024

FDA Viramune Oral Suspension Tablet Instructions Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does…

Istruzzjonijiet tal-Pillola tal-FDA Zyprexa Olanzapine

6 ta’ Lulju, 2024

FDA Zyprexa Olanzapine Tablet Product Information Specifications: Product Name: ZYPREXA Generic Name: Olanzapine Form: Tablet, Orally Disintegrating Product Usage Instructions: Before starting ZYPREXA, read the Medication Guide provided with the…

L-Att dwar il-Modernizzazzjoni tas-Sikurezza tal-Ikel tal-FDA (FSMA) Spiċċaview

Skeda ta' fatti

An fuqview of the FDA Food Safety Modernization Act (FSMA) final rule on mitigation strategies to protect food against intentional adulteration, outlining key requirements, applicability, and resources for the food…

Identification of Medicinal Products: Implementation and Use Guidance

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Guidance for industry on the implementation and use of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. This document outlines the FDA's approach to aligning with…

Understanding Documents, Change Control, and Records in Quality Systems

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A comprehensive guide to document control, device master records (DMR), device history records (DHR), and quality system records (QSR) in the context of FDA regulations and quality systems. Learn about…

Manwal tal-Laboratorju ORA Volum II: Proċedura ta' Azzjoni Preventiva

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This document outlines the preventive action procedure for the Office of Regulatory Science (ORS) laboratories, detailing the process for identifying, evaluating, and implementing actions to prevent nonconformities and improve the…

Bioresearch Monitoring Technical Conformance Guide

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This guide provides FDA specifications, recommendations, and general considerations for preparing and submitting Bioresearch Monitoring (BIMO) clinical data in electronic format for new drug applications (NDAs) and biologics license applications…