FDA Manuals & User Guides

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection User Guide

Disyembre 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

Giaprobahan sa FDA ang Abbott TriClip TEER System User Manual

Nobyembre 11, 2025

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…

Brand: Abbott

FDA ESG NEXTGEN Giya sa Gumagamit sa App

Abril 5, 2025

FDA Electronic Submission Gateway (ESG) NextGen API Guide FDA Electronic Submission Gateway (ESG) NextGen API Guide Application Program Interface Bersyon 1.0 Marso 2025 1. Pasiuna Kini nga dokumento naghatag ug mga giya sa pagsumite files and folders through Application Programming Interfaces (APIs) with…

Brand: FDA

FDA AS2 Electronic Submission Gateway Next Gen User Guide

Abril 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 nga Pamaagi alang sa Tibuok Bay Dahon nga mga Instruksyon

Marso 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 US Food and Drug Administration Center Instruksyon

Marso 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 Instruksyon

Pebrero 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): Petsa sa unang commercial distribution sa Empaveli. Petsa sa paglusad sa Empaveli REMS. Petsa kung kanus-a ang REMS Website became live and…

Brand: FDA

Giya sa Gumagamit sa FDA Authenticator App

Enero 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

Ang FDA Super Retinol Cream alang sa Manwal sa Tag-iya sa Kalalakin-an

Enero 24, 2025

FDA Super Retinol Cream for Men SUPER RETINOL CREAM FOR MEN- super retinol cream for men cream Yiwu Ziqiu Import Export Co Ltd Salicylic acid 2% Instructions for use Wart remove Apply twice daily (morning and night as a man,…

Brand: FDA

Manwal sa Tag-iya sa FDA Mens Plain Face Cream

Enero 24, 2025

FDA Mens Plain Face Cream Specifications Product Type: HUMAN OTC DRUG TOPICAL Item Code (Source): NDC:84522-526 Active Ingredient: Salicylic acid 2% Inactive Ingredients: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORPHENESIN, GLYCERIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL PENTAPEPTIDE-4, SESAME OIL Packaging: 5g in 1…

Brand: FDA

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

Elemental Analysis Manual for Food: ICP-MS Method for Trace Elements

Laboratory Method • December 24, 2025

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.

Brand: FDA

Guidance for Biological Indicator (BI) Premarket Notification [510(k)] Submissions

Guidance Document • December 22, 2025

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.

Brand: FDA

GUDID User Manual: How to Unlock and Edit Device Records in the FDA Database

Manwal sa Gumagamit • Oktubre 29, 2025

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.

Brand: FDA

FDA Food Facility Registration User Guide: Additional Capabilities

Giya sa Gumagamit • Oktubre 14, 2025

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.

Brand: FDA

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

Giya • Oktubre 3, 2025

Usa ka komprehensibo nga dali nga pakisayran nga giya alang sa mga importer ug filers sa pagtaho sa impormasyon ngadto sa FDA alang sa mga regulated nga produkto nga mosulod sa Estados Unidos pinaagi sa Automated Commercial Environment (ACE) system, nga naglangkob sa lain-laing mga kategoriya sa produkto sama sa biologics, mga tambal, pagkaon, medikal nga mga himan, ug tabako.

Brand: FDA

Giya sa Manwal sa Staff sa FDA 1121.934: Northeast Food and Feed Laboratory Organizations and Functions

Staff Manual • September 21, 2025

Opisyal nga FDA Staff Manual Guide 1121.934 nga nagdetalye sa istruktura sa organisasyon ug functional nga mga responsibilidad sa Northeast Food and Feed Laboratory (DCIFCD) ug sa mga sanga niini, lakip ang Chemistry Branch 1, Chemistry Branch 2, ug Microbiological Sciences Branch.

Brand: FDA

Aseptic Processing of Biological Products: Current Regulatory Issues and Manufacturing Challenges

Guidance Document • September 19, 2025

Guidance on current regulatory issues and common deficiencies in aseptic processing of biological products, covering laws, regulations, BLA content, process validation, sterilizing filtration, post-reconstitution/dilution storage, and container closure integrity. Presented by the FDA.

Brand: FDA

Bacteriological Analytical Manual Kapitulo 23: Mga Pamaagi alang sa Kosmetiko - FDA

Manwal • Septiyembre 16, 2025

Komprehensibo nga giya nga nagdetalye sa mga pamaagi sa pagsulay sa microbiological alang sa mga produkto sa kosmetiko, lakip ang sampAng pag-andam, pag-ihap, pag-ila sa mga mikrobyo, ug pagsulay sa pagkaepektibo sa preserbatibo, ingon nga gipatik sa US Food & Drug Administration (FDA).

Brand: FDA

Giya sa FDA ESG NextGen AS2 alang sa mga Gumagamit sa Industriya - Bersyon 2.0

Giya • Septiyembre 12, 2025

Opisyal nga giya alang sa mga tiggamit sa industriya sa pagsumite sa datos pinaagi sa AS2 ngadto sa Electronic Submission Gateway (ESG) NextGen nga sistema sa FDA. Naglangkob sa pag-configure, proseso sa pagsumite, ug pag-troubleshoot.

Brand: FDA

Paghimo sa ACE nga Trabaho alang Kanimo: Pag-import sa Giya sa Gikontrol nga Produkto sa FDA

Giya • Septiyembre 9, 2025

Usa ka komprehensibo nga giya gikan sa US Food and Drug Administration (FDA) nga nagpatin-aw kon unsaon epektibong paggamit sa Automated Commercial Environment (ACE) alang sa pag-import sa mga produkto nga gikontrol sa FDA, nga naglangkob sa mga importanteng proseso, komon nga mga isyu, ug importanteng mga kapanguhaan alang sa hapsay nga operasyon sa pamatigayon.

Brand: FDA

Mga Pagsumite sa ANDA: Giya sa sulud ug Format alang sa Industriya

Guidance • September 1, 2025

Ang giya sa US FDA alang sa industriya sa Minubo nga Bag-ong mga Aplikasyon sa Gamot (ANDAs), nagdetalye sa mga kinahanglanon sa sulud ug pormat gamit ang Common Technical Document (CTD) nga istruktura para sa mga pagsumite sa produkto sa parmasyutiko.

Brand: FDA