The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.
Category Archives: Drug Recalls & Safety Notices
FDA seeks comment on streamlined review of lower risk, new technology, devices
The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet the requirements for clearance under the better-known 510(k) review process
FDA enters consent decree of permanent injunction against Florida drug companies
The U.S. Food and Drug Administration announced today that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc., and Hill Labs, Inc. (collectively referred to as “Hill”), and individuals Jerry S. Roth and Rosario G. Ramirez, from introducing adulterated drugs into interstate commerce.
FDA participates in global efforts to protect consumers and patients from unsafe drugs on the internet
The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.
FDA clears first single use face mask for children
The U.S. Food and Drug Administration has cleared the Kimberly-Clark Pediatric/Child Face Mask, designed to be worn in hospitals and health care facilities to help reduce the spread of airborne respiratory tract bacteria, viruses, and other pathogens.
FDA Warns Consumers Not to Eat Raw Oysters Harvested from Hood Canal Area 4 in Washington State
The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of Hood Canal in Washington State following an outbreak of illness in that state caused by Vibrio parahaemolyticus bacteria.
FDA approves Remicade to treat ulcerative colitis in children 6 years and older
The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy.
FDA approves Soliris for rare pediatric blood disorder
The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
FDA approves Remicade to treat ulcerative colitis in children older than 6 years
The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.