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Latest US Food and Drug Administration Stories

Listeria Deaths Number 29 With 139 Infected From Cantaloupes
2011-11-03 09:23:16

The Centers for Disease Control and Prevention (CDC) said in its latest bulletin yesterday that the number of deaths linked to Colorado-grown cantaloupes tainted with listeria has risen to 29 and 139 people infected across 28 states, Fox News is reporting. Eight deaths have been reported in Colorado; five in New Mexico; three in Kansas; two each in Texas, New York, Missouri and Louisiana; and one each in Indiana, Maryland, Nebraska, Oklahoma and Wyoming. Additionally, a pregnant woman...

2011-11-02 15:06:00

American Botanical Council, American Herbal Pharmacopoeia, and University of Mississippi's National Center for Natural Product Research Join Forces to Educate on Supplement Adulteration Problems, Challenges, and Solutions AUSTIN, Texas, Nov. 2, 2011 /PRNewswire-USNewswire/ -- Three leading nonprofit organizations - the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi's National Center for Natural Products Research...

2011-10-19 10:09:00

NEW YORK, Oct. 19, 2011 /PRNewswire/ -- It is well known that ophthalmologists around the world often prescribe Avastin (bevacizumab) off-label for wet age-related macular degeneration (AMD) over the approved treatment Lucentis (ranibizumabintravitreal) due to cost and the belief that the two have similar efficacy. AMD Alliance International (AMDAI) is calling for ophthalmologists to stop this practice in light of a concerning surge in eye infections over the past month in patients being...

2011-10-05 10:54:00

FDA's Hamburg, AHRQ's Clancy, and Others Address Policy, Practice, Health Law, Informed Consent, and More PLYMOUTH MEETING, Pa., Oct. 5, 2011 /PRNewswire-USNewswire/ -- The term "patient-centeredness" is now enshrined in law by the Affordable Care Act, which created the new Patient Centered Outcomes Research Institute. Patient-centeredness is increasingly embedded in program developments at the federal and state level, and in the private sector, too. But what does patient-centeredness...

2011-10-03 08:00:00

IRVINE, California and AMSTERDAM, October 3, 2011 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company, today announced that the company successfully completed a recent, routine inspection of its Irvine, California-based laboratories by the US Food and Drug Administration (FDA). Agendia received FDA 510(k) clearance for its MammaPrint(R) breast cancer recurrence test in early 2007. It remains the first and only test of its kind to receive FDA clearance,...

2011-09-09 10:25:00

BRUSSELS, September 9, 2011 /PRNewswire/ -- The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA). GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities...

health-082611-001
2011-08-26 05:45:50

  The US Food and Drug Administration (FDA) has banned papaya´s from all of Mexico´s growing regions from entering the US due to an outbreak of salmonella. According to MSNBC's JoNel Aleccia, an FDA investigation found more than 15 percent of fresh papayas entering the US from Mexico were contaminated with the bacteria. The investigation occurred between May 12 and August 18 and was instigated because of an outbreak that sickened over 100 people in 23 states, sending...

health-082511-004
2011-08-25 09:27:14

  The US Food and Drug Administration (FDA) has given approval for Allergan, the maker of Botox, to market the drug to treat a specific kind of overactive bladder condition, Reuters is reporting. After receiving similar approval in Europe earlier this month, US regulators are allowing Botox to be injected into the bladder to treat those who lose bladder control because of damage to the nervous system through conditions such as multiple sclerosis or spinal cord injury. Botox´...

2011-08-09 06:00:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 9, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today results from a Pathology Working Group's (PWG) re-adjudication of female rat mammary tumor diagnoses from a two-year rat carcinogenicity study of lorcaserin. Arena convened the PWG in response to the lorcaserin Complete Response Letter (CRL), which questioned the certainty of the female rat mammary tumor classifications. The PWG reviewed relevant...

2011-08-02 06:00:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 2, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the completion of a clinical study that measured lorcaserin concentrations in human cerebrospinal fluid (CSF) and plasma and related data analyses. The study was conducted to provide additional data that may be informative for determining the human relevance of the observation of brain astrocytoma in male rats. Using the results of this study and...