📘 Mabhuku ekushandisa eFDA • MaPDF epamhepo emahara

Mabhuku eFDA & Gwaro reVashandisi

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.

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

Rutsigiro rweFDA

Nzvimbo yepamutemo: https://www.fda.gov/
General support: https://www.fda.gov/about-fda/contact-fda
Runhare rwekutsigira: 1-888-463-6332 — Mon-Frith 8:00am - 4:30pm ET
email yekutsigira: webmail@oc.fda.gov
Fomu rekuonana: Bata rutsigiro rwemugadziri

Mabhuku ekushandisa eFDA

Mazuvano mabhuku kubva manuals+ yakarongedzwa kune iyi brand.

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,…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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

Gwaro Rokutungamirira

Nhungamiro pamusoro penyaya dziripo dzemutemo uye kusakwana kwakajairika mukugadzirisa zvisina utachiona hwezvinhu zvipenyu, kusanganisira mitemo, mitemo, zviri mukati meBLA, kusimbiswa kwemaitiro, kusefa kwekuuraya utachiona, kuchengetwa mushure mekugadzirisa/kusanganiswa kwemvura, uye kuvimbika kwekuvhara midziyo.

Bhuku Rekuongorora Mabhakitiriya Chitsauko 23: Nzira dzeZvizoro - FDA

Manual

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

FDA ESG NextGen AS2 Gwaro reVashandisi veIndasitiri - Shanduro 2.0

Guide

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

Kuita kuti ACE Ikushandire Iwe: Kupinza FDA Yakadzorwa Zvigadzirwa Gwaro

Guide

A comprehensive guide from the U.S. Food and Drug Administration (FDA) explaining how to effectively use the Automated Commercial Environment (ACE) for importing FDA-regulated products, covering key processes, common issues,…

ANDA Zvinyorwa: Zvemukati uye Format Guidance yeIndasitiri

Nhungamiro

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.

FDA Guide to Documents, Change Control, and Records Management

Guide

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…

Kunzwisisa iyo Pharmaceutical Quality System (PQS) yeFDA Inspections

Guide

An overview of the Pharmaceutical Quality System (PQS) presented by the FDA, focusing on CGMPs, ICH Q10, and FDA inspection strategies. Learn about quality expectations and regulatory requirements for pharmaceutical…

FDA Compliance Program 7356.002: Drug Manufacturing Inspections

Compliance Program

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.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

manual

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.

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

Manual

Bhuku repamutemo rinotsanangura marongero uye maitiro eCentre for Drug Evaluation and Research (CDER) Interdisciplinary Re.view Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

FDA Center yeFodya Zvigadzirwa Hofisi yeCentre Director: Masangano neMashandiro

Bhuku reVashandi

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

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

Kutsanangurwa Kwehunyanzvi

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…