FDA Manuals & User Guides

User manuals, setup guides, troubleshooting help, and repair information for FDA products.

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FDA manuals

Latest posts, featured manuals, and retailer-linked manuals for this brand tag.

FDA Pifeltro Doravirine Tablet of Hiv Infection User Manual

FDA Pifeltro Doravirine Tablet of Hiv Infection User Manual

January 2, 2026
FDA Pifeltro Doravirine Tablet of Hiv Infection INDICATIONS AND USAGE PIFELTRO® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment…
Brand: FDA
FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection User Guide

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection User Guide

December 25, 2025
FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection Specifications Product Name: BLENREP Generic Name: Belantamab Mafodotin-blmf Administration: Intravenous Use Approval Year: 2020 Dosage Form: Lyophilized powder for injection Strength: 70 mg Contraindications There are no contraindications listed for BLENREP use. HIGHLIGHTS…
Brand: FDA
FDA ESG NEXTGEN App User Guide

FDA ESG NEXTGEN App User Guide

April 5, 2025
FDA Electronic Submission Gateway (ESG) NextGen API Guide FDA Electronic Submission Gateway (ESG) NextGen API Guide Application Program Interface Version 1.0 March 2025 1. Introduction This document provides guidelines for submitting files and folders through Application Programming Interfaces (APIs) with…
Brand: FDA
FDA AS2 Electronic Submission Gateway Next Gen User Guide

FDA AS2 Electronic Submission Gateway Next Gen User Guide

April 5, 2025
FDA AS2 Electronic Submission Gateway Next Gen Product Usage Instructions This guide is intended for industry participants who want to utilize AS2 to submit regulatory information to the FDA. The audience includes current AS2 submitters and user technical support resources.…
Brand: FDA
FDA V-8.F Supplemental Method for Whole Bay Leaves Instructions

FDA V-8.F Supplemental Method for Whole Bay Leaves Instructions

March 7, 2025
Macroanalytical Procedures Manual (MPM) V-8. Spices, Condiments, Flavors, and Crude Drugs F. Supplemental Method for Whole Bay Leaves February 2025 Editor (s): Hans Loechelt-Yoshioka Co-editor(s): Amy Barnes, Richard Haynos (Retired) F. Supplemental Method for Whole Bay Leaves Scope This method…
Brand: FDA
FDA U.S. Food and Drug Administration Center Instructions

FDA U.S. Food and Drug Administration Center Instructions

March 6, 2025
U.S. Food and Drug Administration Center for Devices and Radiological Health Digital Health Advisory Committee (DHAC) Meeting on the topic "Total Product Lifecycle Considerations for Generative AI-Enabled Devices" Summary Minutes for Day 1 - November 20, 2024 Introduction On November…
Brand: FDA
FDA NDA 215014-S-008 Empaveli REMS Instructions

FDA NDA 215014-S-008 Empaveli REMS Instructions

February 4, 2025
FDA NDA 215014-S-008 Empaveli REMS Product Usage Instructions Program Implementation and Operations REMS Program Implementation (6-month and 1-year assessments only): Date of first commercial distribution of Empaveli. Date of Empaveli REMS launch. Date when the REMS Website became live and…
Brand: FDA
FDA Authenticator App User Guide

FDA Authenticator App User Guide

January 30, 2025
Multi-factor Authentication User Guide Authenticator App Multi-factor Authentication (MFA) is a security mechanism to build stronger authentication into the LearnED LMS standard login process. Non-FDA Users who are required to log in with MFA must use a mobile device, such…
Brand: FDA
FDA Forms Management Policy and Procedures

FDA Forms Management Policy and Procedures

Staff Manual Guide • December 24, 2025
Official policy and procedural guide from the Food and Drug Administration (FDA) detailing the development, management, and lifecycle of agency forms, including printed and electronic formats, ensuring compliance and efficiency.
Brand: FDA
FDA ACE Supplemental Guide: Industry Quick Reference Guide v2.5.3

FDA ACE Supplemental Guide: Industry Quick Reference Guide v2.5.3

Guide • October 3, 2025
A comprehensive quick reference guide for importers and filers on reporting information to the FDA for regulated products entering the United States via the Automated Commercial Environment (ACE) system, covering various product categories like biologics, drugs, food, medical devices, and tobacco.
Brand: FDA
Making ACE Work for You: Importing FDA Regulated Products Guide

Making ACE Work for You: Importing FDA Regulated Products Guide

Guide • September 9, 2025
A comprehensive guide from the U.S. Food and Drug Administration (FDA) explaining how to effectively use the Automated Commercial Environment (ACE) for importing FDA-regulated products, covering key processes, common issues, and essential resources for smooth trade operations.
Brand: FDA