د FDA لارښودونه او د کارونکي لارښوونې

د FDA میټا کوسټ 3 مخلوط حقیقت هیډسیټ 128 GB کارونکي لارښود

د ۲۰۲۴ کال د جنورۍ ۲۸ مه

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…

د FDA DTP-1 د پراختیا د لارې کارونکي لارښود روښانه کول

د ۲۰۲۳ کال د نومبر ۳۰مه

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…

د FDA معلوماتي ټیکنالوژۍ ستراتیژي کارونکي لارښود

د ۲۰۲۳ کال د نومبر ۳۰مه

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 د متخصصینو لارښوونو شبکه

د اکتوبر ۲۹، ۲۰۲۳

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…

د FDA ناروغ درملو معلوماتو کارونکي لارښود

د اکتوبر ۲۹، ۲۰۲۳

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…

د FDA CDER د بریښنایی ریکارډ ساتلو سیسټمونو مالک لارښود

د اکتوبر ۲۹، ۲۰۲۳

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 د خطر ارزونې او کمولو ستراتیژۍ د مالک لارښود

د اکتوبر ۲۹، ۲۰۲۳

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…

د FDA CDER NextGen پورټل کارونکي لارښود

د اکتوبر ۲۹، ۲۰۲۳

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…

د FDA Midazolam انجکشن لارښوونې

د اکتوبر ۲۹، ۲۰۲۳

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…

د FDA K240280 نانو د RSV ازموینې لارښوونې چیک کړئ

د سپتمبر ۲۵، ۲۰۲۴

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) Number  K240280 B Applicant  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information Product Code(s) Classification Regulation Section…

د اسنادو، بدلون کنټرول، او ریکارډونو مدیریت لپاره د FDA لارښود

لارښود

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…

د FDA معاینې لپاره د درملو کیفیت سیسټم (PQS) پوهیدل

لارښود

یو اوورview 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…

د FDA د اطاعت پروګرام 7356.002: د درملو د تولید معاینې

Compliance Program

دا سند د متحده ایالاتو د خوړو او درملو ادارې د اطاعت پروګرام 7356.002 توضیحات ورکوي، چې د درملو تولید تفتیشونو، د کیفیت تضمین، CGMP اړتیاو، او د درملو محصولاتو لپاره تنظیمي نظارت په اړه لارښوونې چمتو کوي.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

لارښود

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.

د CDER MAPP 6020.14: انټر ډسپلینري Review د QT مطالعاتو د پالیسۍ او طرزالعملونو ټیم

لارښود

د مخدره توکو د ارزونې او څیړنې مرکز (CDER) د بین الډیسپلینري څیړنې لپاره د پالیسیو او طرزالعملونو په اړه رسمي لارښودview Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

FDA Center for Tobacco Products Office of the Center Director: Organizations and Functions

د کارمندانو لارښود

Official staff manual guide detailing the organizational structure and key functions of the Office of the Center Director (DCFA) within the U.S. Food and Drug Administration's Center for Tobacco Products.

د بریښنایی خوندیتوب راپور سپارلو لپاره د ICH E2B(R3) لپاره د FDA سیمه ایز پلي کولو مشخصات

تخنیکي مشخصات

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…

Guide for Preparing FDA Annual Reports on Laser Radiation Safety Testing

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This guide provides instructions for manufacturers and importers on how to prepare and submit annual radiation safety testing reports for laser products and laser light show products to the U.S.…

د FDA اوپیوایډ انالجیزیک REMS: د مسلکي ټولنو لپاره د خوندي نسخې او ضایع کولو په اړه لارښود

لارښوونه

This document provides essential information from the FDA on the Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics, detailing safe disposal methods, continuing education for healthcare providers, and patient…

د روغتیا پاملرنې چمتو کونکو لپاره د FDA اوپیوایډ انالجیسک REMS تعلیمي نقشه

Educational Blueprint

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…

د FDA د خوړو خوندیتوب عصري کولو قانون (FSMA) پای ته ورسیدview

حقیقت پاڼه

یو اوورview of the FDA Food Safety Modernization Act (FSMA) final rule on mitigation strategies to protect food against intentional adulteration, outlining key requirements, applicability, and resources for the food…

د درملو محصولاتو پیژندنه: د تطبیق او کارولو لارښود

لارښود

Guidance for industry on the implementation and use of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. This document outlines the FDA's approach to aligning with…