VYJUVEK
STN: 125774Proper Name: beremagene geperpavec-svdtTradename: VYJUVEKManufacturer: Krystal Biotech, Inc.Indication:For the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1...FDA Online Controlled Substances Summit
Speech by Grace Graham Deputy Commissioner for Policy, Legislation, and International Affairs – Food and Drug Administration Good afternoon. On behalf of the FDA, I am pleased to welcome you to the sixth Online Controlled Substances Summit. Thank you for the...Advancing Generic Drug Development Virtual Workshop
On This Page Date: October 7 – 8, 2025 Day1: Tue, Oct 07 9:00 a.m. – 04:00 p.m. ET Day2: Wed, Oct 08 9:00 a.m. – 03:00 p.m. ET This free, virtual workshop will be hosted on Microsoft Teams. On the day of the workshop, click the “Join Event” button to...Influenza (Flu) Antiviral Drugs and Related Information
Note: Information provided may change and should not be used as a substitute for individual evaluation by a health care provider, or as the primary means of diagnosing influenza or determining treatment. IntroductionThe term influenza refers to illness caused by...Ventilator Recall: Philips Removes Certain DreamStation Devices
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductProduct DescriptionModel...Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps
This recall involves correcting certain devices through a software update and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to...Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most...Annual Reporting
Submit an annual report to FDA Search the annual reporting database Download the database file Annual Licensure Reporting RequirementsWholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure and other...Click To Verify Security & Validation
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