FDA Manuals & User Guides

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…

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Specifications Product Name: TYRUKO Indication: Integrin receptor antagonist for the treatment of Multiple Sclerosis (MS) Dosage Form: Injection Strength: 300 mg/15 mL (20 mg/mL) solution IMPORTANT SAFETY INSORMATION WARNING: PROGRESSIVE MULTIFOCAL…

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…

FDA approves Abbott TriClip TEER System This Patient guide is for those who have severe tricuspid regurgitation (TR) but continue to have symptoms despite being on heart failure medication. Be sure to ask your Heart Team to explain all your…

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…

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.…

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…

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…

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…

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…

This document outlines the policies and procedures for identifying, formatting, and using proprietary names within the Center for Veterinary Medicine (CVM) for animal drug evaluations, including administrative processes and documentation guidelines.

Guidance from the U.S. Food and Drug Administration (FDA) on validating bioanalytical methods for biomarkers in drug development. Covers scope, purpose, and key validation characteristics for nonclinical and clinical studies.

This document outlines the policies, responsibilities, and procedures for the FDA's Center for Drug Evaluation and Research (CDER) Office of New Drugs staff regarding the 'Refuse To File' (RTF) process for New Drug Applications (NDAs) and Biologics License Applications (BLAs).

Guidance from the U.S. Food and Drug Administration (FDA) on creating clear, accessible, and effective user instruction manuals for medical devices intended for home health care. This document assists manufacturers in planning, writing, designing, and testing manuals to ensure safe and effective…

Guidance for the fish and fishery products industry on developing HACCP plans, identifying hazards (biological, chemical, physical), and implementing control strategies for seafood safety, covering pathogens, toxins, allergens, and contaminants.

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.

Detailed laboratory method by the U.S. FDA for determining trace elemental concentrations in food using ICP-MS and Microwave Assisted Digestion. Covers Arsenic, Cadmium, Chromium, Lead, Mercury, and other key elements.

FDA guidance document for industry on preparing Premarket Notification (510(k)) submissions for Biological Indicators (BIs) used in healthcare sterilization monitoring. Covers device description, performance characteristics, and regulatory requirements.

User manual providing instructions on how to unlock and edit device records within the FDA's Global Unique Device Identification Database (GUDID), covering the unlock process, editing procedures, and important considerations for labelers.

A comprehensive user guide from the U.S. Food & Drug Administration (FDA) detailing additional capabilities within the Food Facility Registration (FFR) system, including managing registrations, cancellations, and searching facility information.

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.

Official FDA Staff Manual Guide 1121.934 detailing the organizational structure and functional responsibilities of the Northeast Food and Feed Laboratory (DCIFCD) and its branches, including Chemistry Branch 1, Chemistry Branch 2, and Microbiological Sciences Branch.