News

FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin

25/07/2013 22:14
FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin   The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously...

FDA invites public input on menthol in cigarettes

23/07/2013 22:58
FDA invites public input on menthol in cigarettes   Today, the U.S. Food and Drug Administration issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in...

FDA alerts companies to stop illegal sale of treatments for diabetes

23/07/2013 22:56
FDA alerts companies to stop illegal sale of treatments for diabetes Includes certain products containing undeclared active pharmaceutical ingredients   The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as...

FDA permits marketing of first brain wave test to help assess children and teens for ADHD

15/07/2013 21:36
FDA permits marketing of first brain wave test to help assess children and teens for ADHD   The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and...

FDA approves new treatment for a type of late-stage lung cancer

12/07/2013 22:51
FDA approves new treatment for a type of late-stage lung cancer Companion test also approved to identify appropriate patients   The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose...

FDA proposes “action level” for arsenic in apple juice

12/07/2013 22:48
FDA proposes “action level” for arsenic in apple juice Agency testing and analysis confirm overall safety of apple juice       The U.S. Food and Drug Administration today proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice....

FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization

12/07/2013 22:45
FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization   The U.S. Food and Drug Administration today allowed marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of...

FDA to detain pomegranate seeds offered for import from Goknur of Turkey

29/06/2013 11:54
FDA to detain pomegranate seeds offered for import from Goknur of Turkey Company’s pomegranate seeds may contain Hepatitis A virus The U.S. Food and Drug Administration will detain shipments of pomegranate seeds from Goknur Gida Maddeleri Ithalat Ihracat Tic [Goknur Foodstuffs Import Export...

Federal judge enters consent decree with Med Prep Consulting

28/06/2013 12:42
Federal judge enters consent decree with Med Prep Consulting Sterile injectable drug compounder distributed contaminated drugs across state lines   A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting,...

FDA approves the first non-hormonal treatment for hot flashes associated with menopause

28/06/2013 12:39
FDA approves the first non-hormonal treatment for hot flashes associated with menopause   The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective...
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