Mabhuku eFDA & Gwaro reVashandisi

FDA Super Retinol Cream yeVarume Muridzi Manual

Ndira 24, 2025

FDA Super Retinol Cream for Men SUPER RETINOL CREAM FOR MEN- super retinol cream for men cream Yiwu Ziqiu Import Export Co Ltd Salicylic acid 2% Instructions for use Wart remove Apply twice daily (morning and night as a man,…

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FDA Mens Plain Face Cream Muridzi Manual

Ndira 24, 2025

FDA Mens Plain Face Cream Specifications Product Type: HUMAN OTC DRUG TOPICAL Item Code (Source): NDC:84522-526 Active Ingredient: Salicylic acid 2% Inactive Ingredients: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORPHENESIN, GLYCERIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL PENTAPEPTIDE-4, SESAME OIL Packaging: 5g in 1…

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FDA Anti Aging Cream Muridzi Manual

Ndira 24, 2025

FDA Anti Aging Cream Product Specifications Product Name: Anti-Aging Cream Product Type: Topical Cream Active Ingredient: Niacinamide Strength: 5 g in 100 g Inactive Ingredients: Sesame Oil, Glycerin, Chlorphenesin, Palmitoyl Tripeptide-1, Palmitoyl Pentapeptide-4 Packaging Options: 5 g, 15 g, 30…

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FDA Meta Kutsvaga 3 Yakasanganiswa Reality Headset 128 GB Mushandisi Yekushandisa

Ndira 2, 2025

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide Purpose This document is intended to support users of the Lilypad™ VR experience. It outlines the technical requirements, processes for setup, and steps required to run the Lily pad™…

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FDA DTP-1 Kuvhenekera Iyo Yekuvandudza Nzira Yekushandisa Mushandisi

Mbudzi 27, 2024

Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs Karthika Natarajan Staff Fellow, DTP-1 | ORS | OGD CDER | U.S. FDA Facilitating Generic Drug Product Availability through Product Specific Guidances (PSGs)– April 25, 2024 Combination Products A…

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FDA Ruzivo rweTekinoroji Strategy Mushandisi Gadhi

Mbudzi 13, 2024

FDA Information Technology Strategy for Fiscal Years 2024 to 2027 Message from the CIO I am pleased to share our annual publication of the FDA IT Strategy for FY 2024 — FY 2027. This enterprise plan, shaped by the FDA’s…

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FDA 6001.2 Network of Nyanzvi Mirayiridzo

Gumiguru 28, 2024

FDA 6001.2 Network of Experts Specifications Name: Center for Drug Evaluation and Research (CDER) Network of Experts (NoE) Document: MAPP 6001.2 Rev. 2 Effective Date: 10/23/15; 10/8/21; 2/1/24 Product Information Categories of Issue Requests Category A: General topics in Engineering,…

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FDA Murwere Mushonga Ruzivo Mushandisi Yekushandisa

Gumiguru 23, 2024

Patient Medication Information Product Information Specifications: Product Name: Patient Medication Information (PMI) Type: FDA-approved Medication Guide Storage: Online central repository managed by FDA Accessibility: Freely accessible to the public Product Usage Instructions: What does the proposed rule require? The…

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FDA CDER Electronic Record Kuchengeta Systems Muridzi Chinyorwa

Gumiguru 19, 2024

FDA CDER Electronic Record Keeping Systems PURPOSE This MAPP documents CDER’s Electronic Records Keeping Systems (ERKS) and outlines the policies and procedures for its governance. This includes the following: Definition of a Record and ERKS Identification of the various systems…

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FDA MAPP 6702.1 Review YeRisk Evaluation uye Mitigation Strategy Manual yeMuridzi

Gumiguru 19, 2024

FDA MAPP 6702.1 Review of Risk Evaluation and Mitigation Strategy Specifications Product Name: Manual of Policies and Procedures Center for Drug Evaluation and Research (MAPP 6702.1) Originating Office: Office of Surveillance and Epidemiology Effective Date: 03/25/2024 Product Information The Manual…

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Aseptic Kugadziriswa kweBiological Zvigadzirwa: Zvazvino Zvinetso Zvinetso uye Matambudziko Ekugadzira.

Guidance Document • September 19, 2025

Nhungamiro pazvinhu zvazvino zvekutonga uye kushomeka kwakajairwa mukugadziriswa kweaseptic yezvigadzirwa zvebiological, inovhara mitemo, mirau, BLA zvemukati, gadziriso yekusimbisa, sterilizing kusefa, post-reconstitution / dilution kuchengetedza, uye kuvharwa kwemudziyo kutendeseka. Yakapihwa neFDA.

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Bhuku Rekuongorora Mabhakitiriya Chitsauko 23: Nzira dzeZvizoro - FDA

Bhuku rekushandisa • Gunyana 16, 2025

Gwaro rakakwana rinotsanangura nzira dzekuyedza hutachiona hwezvinhu zvekushongedza, kusanganisira sampkugadzirira, kuverenga, kuzivikanwa kwehutachiona, uye kuyedzwa kwekuchengetedza, sezvakaburitswa neUS Food & Drug Administration (FDA).

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FDA ESG NextGen AS2 Gwaro reVashandisi veIndasitiri - Shanduro 2.0

Gwaro • Gunyana 12, 2025

Nhungamiro yepamutemo yevashandisi veindasitiri pakutumira data kuburikidza neAS2 kune FDA's Electronic Submission Gateway (ESG) NextGen system. Inovhara kumisikidzwa, nzira yekutumira, uye kugadzirisa matambudziko.

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Kuita kuti ACE Ikushandire Iwe: Kupinza FDA Yakadzorwa Zvigadzirwa Gwaro

Gwaro • Gunyana 9, 2025

Gwaro rakazara kubva kuUS Chikafu neDrug Administration (FDA) rinotsanangura mashandisiro ekushandisa Automated Commerce Environment (ACE) kuunza kunze zvigadzirwa zvinodzorwa neFDA, inovhara maitiro akakosha, nyaya dzakajairwa, uye zviwanikwa zvakakosha zvekutengesa kwakatsetseka.

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ANDA Zvinyorwa: Zvemukati uye Format Guidance yeIndasitiri

Guidance • September 1, 2025

US FDA nhungamiro yeindasitiri pane Yakapfupikiswa Zvitsva Zvinodhaka Zvikumbiro (ANDAs), inodonongodza zvirimo uye fomati zvinodiwa uchishandisa iyo Common Technical Document (CTD) chimiro chekutumira zvigadzirwa zvemishonga.

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FDA Guide to Documents, Change Control, and Records Management

Gwaro • Gunyana 1, 2025

Comprehensive guide from the U.S. Food and Drug Administration (FDA) on managing documents, change control, Device Master Records (DMR), Device History Records (DHR), and Quality System Records (QSR) according to 21 CFR Part 820.

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Kunzwisisa iyo Pharmaceutical Quality System (PQS) yeFDA Inspections

Gwaro • Nyamavhuvhu 30, 2025

An overview yePharmaceutical Quality System (PQS) yakapihwa neFDA, yakatarisana neCGMPs, ICH Q10, uye FDA nzira dzekuongorora. Dzidza nezve zvinotarisirwa zvemhando yepamusoro uye zvinotarisirwa pakugadzirwa kwemishonga.

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FDA Compliance Program 7356.002: Drug Manufacturing Inspections

Compliance Program • August 27, 2025

Gwaro iri rinodonongodza iyo US Food and Drug Administration's Compliance Programme 7356.002, ichipa nhungamiro pakuongorora kugadzira zvinodhaka, kuvimbiswa kwemhando, zvinodiwa neCGMP, uye kutarisisa kwezvigadzirwa zvemishonga.

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FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

bhuku rekushandisa • Nyamavhuvhu 27, 2025

This FDA Staff Manual Guide (SMG 2130.11) details the Laboratory Quality Management System (LQMS) for the Food and Drug Administration, covering its purpose, scope, policies, definitions, responsibilities, and document history.

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CDER MAPP 6020.14: Interdisciplinary Review Chikwata cheQT Zvidzidzo Policy uye Matanho

Bhuku rekushandisa • Nyamavhuvhu 26, 2025

Bhuku repamutemo rinotsanangura marongero uye maitiro eCentre for Drug Evaluation and Research (CDER) Interdisciplinary Re.view Chikwata (IRT) chine chekuita neTorough QT (TQT) zvidzidzo, zvinosanganisira gwara remoyo repolarization ongororo yekuvandudzwa kwezvinodhaka.

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FDA Center yeFodya Zvigadzirwa Hofisi yeCentre Director: Masangano neMashandiro

Staff Manual • August 24, 2025

Gwaro revashandi repamutemo rinotsanangura chimiro chesangano uye mabasa akakosha eHofisi yeCenter Director (DCFA) mukati meUS Food and Drug Administration's Center yeFodya Zvigadzirwa.

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FDA Regional Implementation Specifications for ICH E2B(R3) for Electronic Safety Report Submissions

Tsanangudzo yehunyanzvi • Nyamavhuvhu 20, 2025

This document from the U.S. FDA provides technical specifications for submitting Individual Case Safety Reports (ICSRs) for drugs and biologics electronically, adhering to ICH E2B(R3) standards via the Electronic Submissions Gateway (ESG).

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