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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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FDA Midazolam Injection Instructions

FDA Midazolam Injection Instructions

October 10, 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 Test Instructions

FDA K240280 Nano Check RSV Test Instructions

September 30, 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…
FDA h:2250.1 Metered Mail Headquarters Instructions

FDA h:2250.1 Metered Mail Headquarters Instructions

August 23, 2024
FDA h2250.1 Metered Mail  Purpose This Guide sets forth requirements for the metering of outgoing administrative mail at Headquarters locations in order to prepay USPS postage costs. Background In order…
FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

August 15, 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…
FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module User Guide

August 15, 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 Food and Drug Instructions

FDA 2004-N-0451 Food and Drug Instructions

July 31, 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…
FDA Viramune Oral Suspension Tablet Instructions

FDA Viramune Oral Suspension Tablet Instructions

July 6, 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 Olanzapine Tablet Instructions

FDA Zyprexa Olanzapine Tablet Instructions

July 6, 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…
FDA Food Safety Modernization Act (FSMA) Overview

FDA Food Safety Modernization Act (FSMA) Overview

Fact Sheet
An overview 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…
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

guidance
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 applications…