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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.

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Handbækur FDA

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FDA Midazolam stunguleiðbeiningar

FDA Midazolam stunguleiðbeiningar

10. október 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 Product…
FDA K240280 Nano Check RSV prófunarleiðbeiningar

FDA K240280 Nano Check RSV prófunarleiðbeiningar

30. september 2024
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…
Leiðbeiningar FDA h:2250.1 Metered Mail Headquarters

Leiðbeiningar FDA h:2250.1 Metered Mail Headquarters

23. ágúst 2024
FDA h2250.1 Metered Mail Tilgangur Þessi leiðarvísir setur fram kröfur um mælingu á sendandi stjórnunarpósti á höfuðstöðvum til að fyrirframgreiðsla USPS pos.tage costs. Background In order…
FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

15. ágúst 2024
FDA CFSAN Online Submission Module INTRODUCTION This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and illustrate how to assemble an OFAS Regulatory submission. COSM presents…
Notendahandbók FDA CFSAN Submission Module

Notendahandbók FDA CFSAN Submission Module

15. ágúst 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 Usage…
FDA 2004-N-0451 Matvæla- og lyfjaleiðbeiningar

FDA 2004-N-0451 Matvæla- og lyfjaleiðbeiningar

31. júlí 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 Registration…
Leiðbeiningar frá FDA Viramune dreifutöflum

Leiðbeiningar frá FDA Viramune dreifutöflum

6. júlí 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 does…
FDA Zyprexa Olanzapin töfluleiðbeiningar

FDA Zyprexa Olanzapin töfluleiðbeiningar

6. júlí 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 the…
Lyfjaauðkenning: Leiðbeiningar um framkvæmd og notkun

Lyfjaauðkenning: Leiðbeiningar um framkvæmd og notkun

leiðsögn
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…