September 2011 - Sober News

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The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet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

Published Fri, Sep 30 2011 10:25 AM by Food and Drug Administration--Press Releases

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.

Published Thu, Sep 29 2011 1:27 PM by Food and Drug Administration--Press Releases

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.

Published Wed, Sep 28 2011 3:51 PM by Food and Drug Administration--Press Releases

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.

Published Wed, Sep 28 2011 9:13 AM by Food and Drug Administration--Press Releases

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.

Published Mon, Sep 26 2011 5:30 PM by Food and Drug Administration--Press Releases

Mortality among our peers: Better, but not well

Has the disparity actually been reduced in the last five years?

Published Sun, Sep 25 2011 8:00 PM by Behavioral Healthcare Current Articles

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.

Published Fri, Sep 23 2011 4:43 PM by Food and Drug Administration--Press Releases

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.

Published Fri, Sep 23 2011 10:19 AM by Food and Drug Administration--Press Releases

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.

Published Thu, Sep 22 2011 9:00 AM by Food and Drug Administration--Press Releases

FDA confirms Listeria monocytogenes on Jensen Farms’ Rocky Ford-brand cantaloupes

Today, the Food and Drug Administration announced that it found Listeria monocytogenes in samples of Jensen Farms’ Rocky Ford-brand cantaloupe taken from a Denver-area store and on samples taken from equipment and cantaloupe at the Jensen Farms’ packing facility. Tests confirmed that the Listeria monocytogenes found in the samples matches one of the three different strains of Listeria monocytogenes associated with the multi-state outbreak of listeriosis...

Published Mon, Sep 19 2011 5:36 PM by Food and Drug Administration--Press Releases

FDA warns consumers not to eat Rocky Ford Cantaloupes shipped by Jensen Farms

• The FDA is warning consumers not to eat Rocky Ford Cantaloupe shipped by Jensen Farms and to throw away recalled product that may still be in their home. • Jensen Farms is voluntarily recalling Rocky Ford Cantaloupe shipped from July 29 through September 10, 2011, and distributed to at least 17 states with possible further distribution. • The recalled cantaloupes have the potential to be contaminated with Listeria and may be linked to a multi-state...

Published Wed, Sep 14 2011 11:49 PM by Food and Drug Administration--Press Releases

Recovery Month: Share Your Recovery Story

September is National Recovery Month which is designed to promote the message that recovery in all its forms is possible and that people can and do overcome alcoholism and addiction. Nothing sends that message better than the personal stories of those...

Published Wed, Sep 14 2011 9:03 PM by About Alcoholism

September 2011 - Sober News

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