FDA Manuals & User Guides

FDA 21 Vacancy Announcement Product Information Specifications Position: Deputy Office Director Series: AD-0602 Location(s): Silver Spring, Maryland Work Schedule: Full Time Cures Band(s): Band F Salary: Starting at $210,000 Full…

FDA-2023-D-4722 Milk and Cream Products and Yogurt Product Information Specifications Product Name: Milk and Cream Products and Yogurt Products Standards Revoked: Lowfat Yogurt and Nonfat Yogurt Standard Amended: Yogurt Regulatory…

U.S. FOOD & DRUG ADMINISTRATION TangenDx SARS-CoV-2 Molecular Test September 29, 2023 Glenn Neuman RADx Regulatory Consultant New World Regulatory Solutions, Inc. Representing: Tangen Biosciences, Inc. 20 Commercial St. Branford,…

FDA Hold Webinar on the Food Traceability Final Rule User Guide Welcome To Today’s Webinar Thanks for joining us! We’ll get started in a few minutes Today’s Topic: FDA’s Proposed…

FDA AB7500 23A Bacteriological Analytical Important Information Isolation and Identification of Nontuberculous Mycobacteria Associated with Tattoo-related Skin Infections There have been several tattoo-related outbreaks of nontuberculous mycobacterial infection in the…

Instructions for Use ENSPRYNG® (en-spryng) (satralizumab-mwge) Injection Read this Instructions for Use before you start using your prefilled syringe and each time you get a refill. There may be new…

U.S. Food and Drug Administration Center for Tobacco Products (CTP) Product Form Validator Tool User Guide Document Version Number: 1 September 2023 Introduction The FDA Center for Tobacco Products (CTP)…

EXECUTIVE SUMMARY FOR THE PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING Advancing Health Equity in Medical Devices Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or…

FDA Department of Health and Human Services Instructions Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Biologics Evaluation and Research…

FDA Optilume BPH Catheter System Product Information The Optilume BPH Catheter System is a medical device designed for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH)…