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.

Bhuku rekushandisa reFDA Pifeltro Doravirine Tablet yeHIV

Ndira 2, 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…

Mutengo: FDA

FDA natalizumab-sztn Tyruko Mirayiridzo yeBiosimilar yeSclerosis Yekutanga uye Yega

Ndira 1, 2026

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Specifications Zita rechigadzirwa: TYRUKO Chiratidzo: 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…

Mutengo: FDA

Gwaro Rekushandisa reFDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection

Zvita 25, 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…

Mutengo: FDA

FDA yabvumidza bhuku reAbbott TriClip TEER System User Manual

Mbudzi 11, 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…

Mutengo: Abbott

FDA ESG NEXTGEN App User Guide

Kubvumbi 5, 2025

FDA Electronic Submission Gateway (ESG) NextGen API Guide FDA Electronic Submission Gateway (ESG) NextGen API Guide Application Programme Interface Version 1.0 Kurume 2025 1. Nhanganyaya Gwaro rino rinopa gwara rekutumira. files and folders through Application Programming Interfaces (APIs) with…

Mutengo: FDA

FDA AS2 Yemagetsi Kutumira Gedhi Inotevera Gen Mushandisi Yekushandisa

Kubvumbi 5, 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.…

Mutengo: FDA

FDA V-8.F Supplemental Method for Whole Bay Leaves Instructions

Kurume 7, 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…

Mutengo: FDA

FDA US Food and Drug Administration Center Mirayiridzo

Kurume 6, 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…

Mutengo: FDA

FDA NDA 215014-S-008 Empaveli REMS Mirayiridzo

Kukadzi 4, 2025

FDA NDA 215014-S-008 Empaveli REMS Product Usage Instructions Programme Implementation and Operations REMS Program Implementation (6-mwedzi uye 1-gore kuongorora chete): Zuva rekutanga kugoverwa kwekutengeserana kweMpaveli. Zuva reMpaveli REMS kutanga. Zuva iro REMS Website became live and…

Mutengo: FDA

FDA Authenticator App User Guide

Ndira 30, 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…

Mutengo: 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.

Mutengo: 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.

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

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).

Mutengo: FDA

Nyora Zvakarurama: Mazano Ekugadzira Mabhuku Emirayiridzo Yevashandisi Yekushandisa Zvishandiso Zvekurapa Zvekuchengetedza Hutano Mumba

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…

Mutengo: FDA

Njodzi neZvigadzirwa zveHove neHove Njodzi neKudzora - Chinyorwa Chechina

Guidance • December 31, 2025

Gwaro rebazi rehove nezvigadzirwa zvehove pakugadzira zvirongwa zveHACCP, kuona njodzi (dzezvipenyu, dzemakemikari, dzemuviri), uye kushandisa nzira dzekudzora kuchengetedzeka kwehove, kuvhara hutachiona, chepfu, zvinhu zvinokonzera allergy, uye zvinosvibisa.

Mutengo: FDA

Mutemo weKutarisira Mafomu eFDA uye Maitiro

Staff Manual Guide • December 24, 2025

Gwaro repamutemo remitemo uye maitiro kubva kuFood and Drug Administration (FDA) rinotsanangura kugadzirwa, manejimendi, uye hupenyu hwemafomu esangano, kusanganisira mafomati akadhindwa uye emagetsi, zvichiona kuti zvinotevedzwa uye zvinoshanda.

Mutengo: FDA

Bhuku Rekuongorora Zvekudya: Nzira yeICP-MS yeTrace Elements

Laboratory Method • December 24, 2025

Nzira yakadzama yekurabhoritari neUS FDA yekuona huwandu hwezvinhu zviri muchikafu uchishandisa ICP-MS uye Microwave Assisted Digestion. Inofukidza Arsenic, Cadmium, Chromium, Lead, Mercury, nezvimwe zvinhu zvakakosha.

Mutengo: FDA

Gwaro reChiratidzo cheBiological (BI) Premarket Notification [510(k)] Zvinyorwa

Guidance Document • December 22, 2025

Gwaro reFDA rekutungamira indasitiri pakugadzirira Premarket Notification (510(k)) kutumira Biological Indicators (BIs) inoshandiswa mukutarisa hutano hwekudzivirira hutachiona. Rinofukidza tsananguro yemudziyo, hunhu hwekushanda, uye zvinodiwa nemitemo.

Mutengo: FDA

Bhuku reMushandisi reGUDID: Maitiro Ekuvhura uye Kugadzirisa Zvinyorwa zveChishandiso muFDA Database

Bhuku reMushandisi • Gumiguru 29, 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.

Mutengo: FDA

Gwaro Rekushandisa reKunyoresa Nzvimbo Yekudya yeFDA: Zvimwe Zvikwanisiro

Gwaro Rekushandisa • Gumiguru 14, 2025

Gwaro rekushandisa rakazara kubva kuUS Food & Drug Administration (FDA) rinotsanangura mamwe mabasa ari muFood Facility Registration (FFR), kusanganisira kugadzirisa kunyoresa, kukanzura, uye ruzivo rwenzvimbo yekutsvaga.

Mutengo: FDA

FDA ACE Supplemental Guide: Indasitiri Inokurumidza Reference Guide 2.5.3

Gwaro • Gumiguru 3, 2025

Iyo yakazara yekukurumidza referensi dhairekitori kune vanopinza uye filers pamusoro pekuzivisa ruzivo kuFDA kune zvigadzirwa zvine mutemo zvinopinda muUnited States kuburikidza neAutomated Commerce Environment (ACE) system, inovhara akasiyana ezvigadzirwa zvemhando sebiologics, zvinodhaka, chikafu, mishonga yekurapa, uye fodya.

Mutengo: FDA

FDA Staff Manual Guide 1121.934: Northeast Food and Feed Laboratory Masangano neMabasa

Staff Manual • September 21, 2025

Official FDA Staff Manual Guide 1121.934 inodonongodza chimiro chesangano uye mabasa anoshanda eNortheast Food and Feed Laboratory (DCIFCD) nemapazi ayo, anosanganisira Chemistry Branch 1, Chemistry Branch 2, uye Microbiological Sayenzi Bazi.

Mutengo: FDA