FDA Manuals & User Guides

FDA ORA-1264078 Hard Plates Ballistic Inserts Instruction Manual

March 25, 2023

The Food and Drug Administration, Office of Regulatory Affairs (FDA, ORA) FDA/ORA OHAFO Division of Domestic Human and Animal Food Operations  Request for Quotation: FDA-ORA-1264078  Hard Plates Ballistic Inserts  March…

FDA 1243.5741 Center For Veterinary Medicine Program Policy Instruction Manual

March 25, 2023

1243.5741 Center For Veterinary Medicine Program Policy Instruction Manual CENTER FOR VETERINARY MEDICINE PROGRAM POLICY AND PROCEDURES MANUAL MEMORANDUM RECOMMENDING APPROVAL (MRA) FOR ORIGINAL AND SUPPLEMENTAL (ABBREVIATED) NEW ANIMAL DRUG…

FDA DAYVIGO Tablet Instruction Manual

January 13, 2023

FDA DAYVIGO Tablet HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DAYVIGO® safely and effectively. See full prescribing information for DAYVIGO®. DAYVIGO® (lemborexant)…

FDA Assure-100 Rapid COVID-19 Home Test Instruction Manual

January 3, 2023

Rapid COVID-19 Home Test Assure-100 Rapid COVID-19 Home Test For use under Emergency Use Authorization (EUA) only.Carefully read instructions before performing test.Failure to follow the instructions may result in inaccurate…

FDA CVM eSubmitter Data Book User Guide

November 29, 2022

FDA CVM eSubmitter Data Book User Guide Introduction The value of the Data Book is to provide a means of storing information from within a section of a submission to…

FDA CVM eSubmitter Master File User Guide

November 25, 2022

FDA CVM eSubmitter Master File Introduction The Master File Book provides a means of storing Master File information to be reused across submissions and associated books. Reusing this data makes…

FDA COVID-19 Nano Test Instruction Manual

November 24, 2022

FDA COVID-19 Nano Test Instruction Manual The Nano Test for COVID-19 will be performed at Nanobiosym Precision Testing Services, located at 245 First Street, Suite 175, Cambridge, MA 02142, that…

FDA Food Facility Registration User Guide

August 29, 2022

FDA Food Facility Registration IMPORTANT INSTRUCTION Step 1 – Select the registration you want to update Once you are logged in to FDA Industry Systems/your Online Account Administration (OAA) account,…

FDA CVM eSubmitter ADMS Book Electronic Submission Software User Guide

July 23, 2022

CVM eSubmitter Animal Drug and Manufacturing (ADMS) Book Quick Guide  Introduction This guide outlines the functions associated with viewing and managing establishment information and supply chains in the Animal Drugs…

FDA SGR 129 Fish and Fishery Products Hazards and Controls User Guide

July 20, 2022

FDA SGR 129 Fish and Fishery Products Hazards and Controls Additional copies may be purchased from: Florida Sea Grant IFAS - Extension Bookstore University of Florida P.O. Box 110011 Gainesville,…