📘 Imibhalo ye-FDA • Ama-PDF aku-inthanethi wamahhala

Amamanyuwali we-FDA & Imihlahlandlela Yomsebenzisi

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.

Ithiphu: faka inombolo yemodeli egcwele ephrintwe kulebula yakho ye-FDA ngokufana okuhle kakhulu.

Ukusekela kwe-FDA

Isayithi elisemthethweni: https://www.fda.gov/
Ukwesekwa okuvamile: https://www.fda.gov/about-fda/contact-fda
Ifoni yokusekela: 1-888-463-6332 — Mon-Fri 8:00am - 4:30pm ET
I-imeyili yosekelo: webmail@oc.fda.gov
Ifomu lokuxhumana: Xhumana nosekelo lomkhiqizi

Izincwadi ze-FDA

Izincwadi zakamuva ezivela manuals+ ikhethelwe lolu hlobo.

I-FDA Mens Plain Face Cream Owner's Manual

Januwari 24, 2025

I-FDA Mens Plain Face Cream Ukucaciswa Uhlobo Lomkhiqizo: HUMAN OTC DRUG TOPICAL Item Item (Umthombo): NDC:84522-526 Isithako Esisebenzayo: Salicylic acid 2% Izithako Ezingasebenzi: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORICENESIN, CHLORICNERESIN, CHLORIN, CHLORIN

I-FDA Anti Aging Cream Owner's Manual

Januwari 24, 2025

Ukucaciswa Komkhiqizo Wokhilimu Wokuguga We-FDA Igama Lomkhiqizo: Uhlobo Lomkhiqizo Lokhilimu Olwa Ukuguga: Isithako Esisebenzayo Sokhilimu Wesihloko: Amandla e-Niacinamide: 5 g ku-100 g Izithako Ezingasebenzi: Amafutha Esame, I-Glycerin, I-Chlorphenesin, I-Palitoyl...

I-FDA Meta Quest 3 Mixed Reality Headset 128 GB Umhlahlandlela Womsebenzisi

Januwari 2, 2025

I-FDA Meta Quest 3 Mixed Reality Headset 128 GB Umhlahlandlela Womsebenzisi Injongo Lo mbhalo uhloselwe ukusekela abasebenzisi be-Lilypad™ VR. Iveza izidingo zobuchwepheshe, izinqubo...

I-FDA DTP-1 Ikhanyisa Umhlahlandlela Womsebenzisi Wendlela Yokuthuthukiswa

Novemba 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…

I-FDA Information Technology Strategy Umhlahlandlela Womsebenzisi

Novemba 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…

I-FDA 6001.2 Inethiwekhi Yeziqondiso Zochwepheshe

Okthoba 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…

Umhlahlandlela Womsebenzisi Wolwazi Lomuthi Wesiguli we-FDA

Okthoba 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…

I-FDA CDER Electronic Record Keeping Systems Incwadi Yomnikazi

Okthoba 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…

I-FDA MAPP 6702.1 Review Yokuhlola Ubungozi kanye Nebhukwana Lomnikazi Wesu Lokunciphisa

Okthoba 19, 2024

I-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…

I-FDA CDER NextGen Portal User Guide

Okthoba 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…

Ukwenza I-ACE Isebenzele Wena: Ukungenisa Umhlahlandlela Wemikhiqizo Elawulwa yi-FDA

Umhlahlandlela

Umhlahlandlela ophelele ovela kwa-US Food and Drug Administration (FDA) ochaza indlela yokusebenzisa ngempumelelo i-Automated Commercial Environment (ACE) ekungeniseni imikhiqizo elawulwa yi-FDA, ehlanganisa izinqubo ezibalulekile, izinkinga ezivamile,…

Ukuhanjiswa kwe-ANDA: Umhlahlandlela Wokuqukethwe kanye Nefomethi Yemboni

Isiqondiso

Isiqondiso se-US FDA semboni mayelana nezicelo ezifushanisiwe zemithi emisha (ama-ANDA), echaza izidingo zokuqukethwe nefomethi kusetshenziswa isakhiwo se-Common Technical Document (CTD) ekuthunyelweni kwemikhiqizo yezemithi.

I-FDA Guide to Documents, Change Control, and Records Management

Umhlahlandlela

Umhlahlandlela ophelele ovela ku-US Food and Drug Administration (FDA) mayelana nokuphatha amadokhumenti, ukulawulwa koshintsho, Amarekhodi Enkosi Yedivayisi (DMR), Amarekhodi Omlando Wedivayisi (DHR), kanye namarekhodi Esistimu Yekhwalithi (QSR) ngokusho...

Ukuqonda Uhlelo Lwekhwalithi Yezemithi (PQS) Lokuhlolwa Kwe-FDA

Umhlahlandlela

Kuphelileview ye-Pharmaceutical Quality System (PQS) eyethulwe yi-FDA, igxile kuma-CGMP, ICH Q10, namasu okuhlola e-FDA. Funda mayelana nekhwalithi elindelwe kanye nezimfuneko zokulawula zemithi…

I-FDA Compliance Programme 7356.002: Ukuhlolwa Kokukhiqiza Izidakamizwa

Uhlelo Lokuhambisana

Lo mbhalo ucacisa ngoHlelo Lokuthobela Lokulawulwa Kokudla Nezidakamizwa lwase-US 7356.002, olunikeza isiqondiso mayelana nokuhlolwa kokukhiqizwa kwezidakamizwa, ukuqinisekiswa kwekhwalithi, izidingo ze-CGMP, kanye nokwengamela okusemthethweni kwemikhiqizo yezemithi.

Amamanyuwali we-FDA & Imihlahlandlela Yomsebenzisi

Izincwadi ze-FDA

I-FDA Mens Plain Face Cream Owner's Manual

I-FDA Anti Aging Cream Owner's Manual

I-FDA Meta Quest 3 Mixed Reality Headset 128 GB Umhlahlandlela Womsebenzisi

I-FDA DTP-1 Ikhanyisa Umhlahlandlela Womsebenzisi Wendlela Yokuthuthukiswa

I-FDA Information Technology Strategy Umhlahlandlela Womsebenzisi

I-FDA 6001.2 Inethiwekhi Yeziqondiso Zochwepheshe

Umhlahlandlela Womsebenzisi Wolwazi Lomuthi Wesiguli we-FDA

I-FDA CDER Electronic Record Keeping Systems Incwadi Yomnikazi

I-FDA MAPP 6702.1 Review Yokuhlola Ubungozi kanye Nebhukwana Lomnikazi Wesu Lokunciphisa

I-FDA CDER NextGen Portal User Guide

Ukwenza I-ACE Isebenzele Wena: Ukungenisa Umhlahlandlela Wemikhiqizo Elawulwa yi-FDA

Ukuhanjiswa kwe-ANDA: Umhlahlandlela Wokuqukethwe kanye Nefomethi Yemboni

I-FDA Guide to Documents, Change Control, and Records Management

Ukuqonda Uhlelo Lwekhwalithi Yezemithi (PQS) Lokuhlolwa Kwe-FDA

I-FDA Compliance Programme 7356.002: Ukuhlolwa Kokukhiqiza Izidakamizwa

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

CDER MAPP 6020.14: Interdisciplinary Review Team for QT Studies Policy and Procedures

I-FDA Center for Tobacco Products Ihhovisi Lomqondisi Wesikhungo: Izinhlangano Nemisebenzi

I-FDA Regional Implementation Specifications ye-ICH E2B(R3) Yokulethwa Kombiko Wokuphepha Ngogesi

Guide for Preparing FDA Annual Reports on Laser Radiation Safety Testing

I-FDA ye-Opioid Analgesic REMS: Isiqondiso Semiphakathi Yochwepheshe Ngokunikezwa Nokulahlwa Okuphephile

I-FDA Opioid Analgesic REMS Education Blueprint yabahlinzeki bezempilo