FDA qo'llanmalari va foydalanuvchi qo'llanmalari

FDA erkaklar uchun oddiy yuz kremi foydalanuvchi qo'llanmasi

24 yil 2025 yanvar

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 qarishga qarshi krem ​​foydalanuvchi qo'llanmasi

24 yil 2025 yanvar

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 Quest 3 aralash haqiqat eshitish vositasi 128 GB foydalanuvchi qo'llanmasi

2 yil 2025 yanvar

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 Rivojlanish yo'lini yoritish foydalanuvchi qo'llanmasi

27 yil 2024 noyabr

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 axborot texnologiyalari strategiyasi foydalanuvchi qo'llanmasi

13 yil 2024 noyabr

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 Ekspertlar ko'rsatmalari tarmog'i

28 yil 2024 oktyabr

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 bemorlarning dori-darmonlari haqida foydalanuvchi qo'llanmasi

23 yil 2024 oktyabr

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 elektron yozuvlarni saqlash tizimlari foydalanuvchi qo'llanmasi

19 yil 2024 oktyabr

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 Xatarlarni baholash va kamaytirish strategiyasi foydalanuvchi qo'llanmasi

19 yil 2024 oktyabr

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 foydalanuvchi qo'llanmasi

19 yil 2024 oktyabr

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…

ACE siz uchun ishlashi: FDA tomonidan tartibga solinadigan mahsulotlarni import qilish bo'yicha qo'llanma

Qoʻllanma

AQSh Oziq-ovqat va farmatsevtika idorasi (FDA) tomonidan FDA tomonidan tartibga solingan mahsulotlarni import qilish uchun Avtomatlashtirilgan tijorat muhitidan (ACE) qanday samarali foydalanishni tushuntiruvchi keng qamrovli qo'llanma, asosiy jarayonlar, keng tarqalgan muammolar va boshqalarni qamrab oladi...

ANDA taqdimotlari: Sanoat uchun tarkib va ​​format bo'yicha ko'rsatmalar

Yo'l-yo'riq

AQSH FDA sanoat uchun qisqartirilgan yangi dori ilovalari (ANDAs) boʻyicha yoʻriqnomasi, farmatsevtika mahsulotlarini yuborish uchun Umumiy Texnik Hujjat (CTD) tuzilmasidan foydalangan holda tarkib va ​​format talablarini batafsil bayon qiladi.

FDA Guide to Documents, Change Control, and Records Management

Qoʻllanma

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…

FDA tekshiruvlari uchun farmatsevtika sifati tizimini (PQS) tushunish

Qoʻllanma

Bittaview 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 muvofiqlik dasturi 7356.002: Dori vositalarini ishlab chiqarish tekshiruvlari

Compliance Program

Ushbu hujjatda AQSH Oziq-ovqat va farmatsevtika idorasining 7356.002 muvofiqlik dasturi batafsil bayon etilgan boʻlib, dori vositalarini ishlab chiqarish tekshiruvlari, sifat kafolati, CGMP talablari va farmatsevtika mahsulotlari uchun tartibga soluvchi nazorat boʻyicha koʻrsatmalar beradi.

FDA Staff Manual Guide SMG 2130.11: Laboratory Quality Management System

qo'llanma

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: Fanlararo Review QT tadqiqotlari siyosati va tartiblari bo'yicha guruh

Qo'llanma

Giyohvand moddalarni baholash va tadqiqot markazi (CDER) fanlararo Re uchun siyosat va tartib-qoidalar haqida batafsil ma'lumot beruvchi rasmiy qo'llanmaview Team (IRT) concerning Thorough QT (TQT) studies, including guidance on cardiac repolarization…

Markaz direktorining tamaki mahsulotlari bo'yicha FDA markazi: Tashkilotlar va funktsiyalar

Xodimlar qo'llanmasi

AQSh Oziq-ovqat va farmatsevtika idorasining Tamaki mahsulotlari markazidagi Markaz direktori idorasining (DCFA) tashkiliy tuzilmasi va asosiy vazifalari haqida batafsil ma'lumot beruvchi rasmiy xodimlar uchun qo'llanma.

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

Texnik spetsifikatsiya

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

Qoʻllanma

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.…

FDA opioid analjezik REMS: Xavfsiz retseptlash va yo'q qilish bo'yicha professional jamiyatlar uchun ko'rsatma

Yo'l-yo'riq

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…

FDA opioid analjezik REMS sog'liqni saqlash provayderlari uchun ta'lim rejasi

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…