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Pentadbiran Makanan dan Ubat-ubatan AS (FDA) ialah agensi persekutuan yang bertanggungjawab melindungi kesihatan awam dengan mengawal selia makanan, ubat-ubatan, peralatan perubatan, kosmetik dan banyak lagi.

Petua: sertakan nombor model penuh yang dicetak pada label FDA anda untuk padanan terbaik.

Manual FDA

Manual terkini daripada manuals+ dipilih susun untuk jenama ini.

Arahan Suntikan Midazolam FDA

Arahan Suntikan Midazolam FDA

10 Oktober 2024
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 Productā€¦
FDA K240280 Nano Semak Arahan Ujian RSV

FDA K240280 Nano Semak Arahan Ujian RSV

30 September 2024
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) NumberĀ  K240280 B ApplicantĀ  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information ProductĀ Code(s) Classification RegulationĀ Sectionā€¦
FDA h:2250.1 Arahan Ibu Pejabat Mel Bermeter

FDA h:2250.1 Arahan Ibu Pejabat Mel Bermeter

23 Ogos 2024
FDA h2250.1 Mel Bermeter Tujuan Panduan ini menetapkan keperluan untuk pemeteran mel pentadbiran keluar di lokasi Ibu Pejabat untuk prabayar pos USPStage costs. Background In orderā€¦
Panduan Pengguna Modul Penyerahan FDA CFSAN

Panduan Pengguna Modul Penyerahan FDA CFSAN

15 Ogos 2024
FDA CFSAN Submission Module Product Information Specifications Product Name: CFSAN Online Submission Module (COSM) Availability: 24 hours, 7 days a week Developed for: Transmitting submissions to FDA's CFSAN Product Usageā€¦
FDA 2004-N-0451 Arahan Makanan dan Ubat

FDA 2004-N-0451 Arahan Makanan dan Ubat

31 Julai 2024
FDA 2004-N-0451 Food and Drug Specifications Product Name: Food and Drug Administration Modernization Act of 1997 Recognition List Number: 062 Agency: Food and Drug Administration, HHS Product Usage Instructions Registrationā€¦
Arahan Tablet Suspensi Oral FDA Viramune

Arahan Tablet Suspensi Oral FDA Viramune

6 Julai 2024
FDA Viramune Oral Suspension Tablet Instructions Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information doesā€¦
Arahan Tablet Zyprexa Olanzapine FDA

Arahan Tablet Zyprexa Olanzapine FDA

6 Julai 2024
FDA Zyprexa Olanzapine Tablet Product Information Specifications: Product Name: ZYPREXA Generic Name: Olanzapine Form: Tablet, Orally Disintegrating Product Usage Instructions: Before starting ZYPREXA, read the Medication Guide provided with theā€¦
Manual Makmal ORA Jilid II: Prosedur Tindakan Pencegahan

Manual Makmal ORA Jilid II: Prosedur Tindakan Pencegahan

manual
This document outlines the preventive action procedure for the Office of Regulatory Science (ORS) laboratories, detailing the process for identifying, evaluating, and implementing actions to prevent nonconformities and improve theā€¦
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

bimbingan
This guide provides FDA specifications, recommendations, and general considerations for preparing and submitting Bioresearch Monitoring (BIMO) clinical data in electronic format for new drug applications (NDAs) and biologics license applicationsā€¦