Mabhuku eFDA & Gwaro reVashandisi

Mabhuku ekushandisa, nhungamiro dzekugadzirisa, rubatsiro rwekugadzirisa matambudziko, uye ruzivo rwekugadzirisa zvigadzirwa zveFDA.

Zano: isa nhamba yakazara yemhando yakadhindwa pane yako FDA label kuti uwane mhando yakakodzera.

Mabhuku ekushandisa eFDA

Zvinyorwa zvitsva, mabhuku ekushandisa akakurumbira, uye mabhuku ekushandisa akabatana nevatengesi vemhando iyi tag.

FDA CDER NextGen Portal User Guide

FDA CDER NextGen Portal User Guide

Gumiguru 19, 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 Login: To request a login on the CDER NextGen Portal:ā€¦
Mutengo: FDA
FDA Midazolam Jekiseni Mirayiridzo

FDA Midazolam Jekiseni Mirayiridzo

Gumiguru 10, 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 Usage Instructions Step 1: Preparation Ensure you have the Midazolamā€¦
Mutengo: FDA
FDA K240280 Nano Tarisa RSV Test Mirayiridzo

FDA K240280 Nano Tarisa RSV Test Mirayiridzo

Gunyana 30, 2024
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) NumberĀ  K240280 B ApplicantĀ  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information ProductĀ Code(s) Classification RegulationĀ Section Panel GQG Class I 21 CFR 866.3480 -Ā Respiratory Syncytial Virusā€¦
Mutengo: FDA
FDA h:2250.1 Metered Mail Headquarters Mirayiridzo

FDA h:2250.1 Metered Mail Headquarters Mirayiridzo

Nyamavhuvhu 23, 2024
FDA h2250.1 Metered Mail Chinangwa Ichi Gwaro rinotaridza zvinodiwa pakuyera meta yetsamba inobuda yehutungamiri panzvimbo dzeHofisi kuitira kuti ubhadhare USPS pos.tage mari. Background Kuti unyatso ongorora postage costs and more effectively satisfyā€¦
Mutengo: FDA
FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

Nyamavhuvhu 15, 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 you with questions in a simple and consistent format toā€¦
Mutengo: FDA
FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module User Guide

Nyamavhuvhu 15, 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 Instructions COSM Registration Process The COSM registration process involves creatingā€¦
Mutengo: FDA
FDA 2004-N-0451 Chikafu neMishonga Mirayiridzo

FDA 2004-N-0451 Chikafu neMishonga Mirayiridzo

Chikunguru 31, 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 for Workshop Attendance To attend the workshop, registration is required.ā€¦
Mutengo: FDA
FDA Viramune Oral Suspension Tablet Mirayiridzo

FDA Viramune Oral Suspension Tablet Mirayiridzo

Chikunguru 6, 2024
Mirayiridzo yepiritsi reFDA Viramune Oral Suspension Verenga gwaro iri remushonga usati watanga kutora VIRAMUNE uye pese paunowana mushonga wekuwedzera. Panogona kunge paine ruzivo rutsva. Ruzivo urwu harutore nzvimbo yekutaura nachiremba wako nezveā€¦
Mutengo: FDA
FDA Opioid Analgesic REMS Dzidzo Blueprint yeVanopa Hutano

FDA Opioid Analgesic REMS Dzidzo Blueprint yeVanopa Hutano

Educational Blueprint ā€¢ August 18, 2025
This document outlines the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) educational blueprint for healthcare providers. It covers essential knowledge for treating and monitoring patients with pain, including pain management fundamentals, opioid risks, safe prescribing practices, patient counseling, and addictionā€¦
Mutengo: FDA
FDA Food Safety Modernization Act (FSMA) Pamusoroview

FDA Food Safety Modernization Act (FSMA) Pamusoroview

Fact Sheet ā€¢ August 6, 2025
An overview yeFDA Chikafu Chekuchengetedza Modernization Act (FSMA) mutemo wekupedzisira panzira dzekudzikisa kudzivirira chikafu kubva mukupindwa nemaune, kutsanangura zvakakosha zvinodiwa, kushanda, uye zviwanikwa zveindasitiri yechikafu.
Mutengo: FDA
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

guidance ā€¢ July 28, 2025
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 (BLAs). It details requirements for Clinical Study-Level Information, Subject-Level Data Line Listingsā€¦
Mutengo: FDA