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Latest FDA News and Information
FDA Updates Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture?s Food Safety and Inspection Service, continues to work... read more
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly... read more
United States Seizes more than 1500 Cases of Food from Wisconsin Distribution Warehouse
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions... read more
FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect... read more
Food and Drug Adminstration (FDA): CDRHNew
510(k) Final Decisions - January 2010
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Guidance for Industry and FDA Staff
This document provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods.
Class I Medical Device Recall: Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport
Reason for Recall: The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood... read more
What's New: Vaccines, Blood Biologics RSS Feed
Zostavax
December 18, 2009 Approval Letter, Summary Basis for Regulatory Action, updated Package Insert and Patient Information to include the statement that Zostavax and Pneumovax 23 should not be given concurrently.
Biologic Product Shortages
Complete List of Substantially Equivalent 510(k) Device Applications
Information updated through January 31, 2010
Complete List of Currently Approved Premarket Approvals (PMAs)
Information updated through January 31, 2010
