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Daily news and top headlines for manufacturing professionals

FDA Issues Regulatory Science Report

October 6, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

Regulatory Science, report, initiative

FDA awards $904,000 to Pan American Health Organization for information ‘hub’

October 6, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

PAHO

FDA awards nearly $3 million for TB research

October 6, 2010 5:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

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FDA schedules public hearing on Biologics Price Competition and Innovation Act

October 4, 2010 6:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2 - 3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA’s White Oak Campus, 10903 New...

No laps for warm laptops; skin damage is possible

October 4, 2010 5:35 am | by LINDSEY TANNER - AP Medical Writer - Associated Press | News | Comments

Have you ever worked on your laptop computer with it sitting on your lap, heating up your legs? If so, you might want to rethink that habit.Doing it a lot can lead to "toasted skin syndrome," an unusual-looking mottled skin condition caused by long-term heat exposure, according to medical...

FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine

September 30, 2010 10:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial...

Deaths prompt CPSC, FDA warning on infant sleep positioners

September 29, 2010 8:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners.

Amgen Pulls Anemia Drugs Due To Glass Flakes

September 24, 2010 5:59 am | News | Comments

Biotechnology company is recalling some lots of its Epogen and Procrit anemia treatments because they may contain glass flakes.

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Medline Industries Plans Georgia Plant

September 24, 2010 5:04 am | News | Comments

An Illinois-based manufacturer of medical supplies says it plans to open a manufacturing plant in Douglas County, creating 141 jobs.

Qualcomm Joins African Telecommunications Union

September 23, 2010 11:45 am | by Qualcomm | News | Comments

Nairobi, Kenya – September 23, 2010 – African Telecommunications Union (ATU) and Qualcomm Incorporated (NASDAQ: QCOM) today announced that Qualcomm has joined the ATU as an associate member. The Company will work together with the ATU’s 18 other associate members and 46 members toward...

Cleveland Clinic to research head injuries

September 23, 2010 4:36 am | by BARRY WILNER - AP Pro Football Writer - Associated Press | News | Comments

The Cleveland Clinic is combining with helmet-maker Rawlings on independent research of concussions and other sports-related head and neck injuries that could include measuring the impact on the brain.Doctors and scientists from the clinic's Neurological Institute and its Spine Research Laboratory...

Surmodics names former Medtronic exec to board

September 22, 2010 2:36 pm | by The Associated Press | News | Comments

Drug delivery company SurModics Inc. said Wednesday it added a former executive from Medtronic Inc. to its board of directors.Surmodics said Scott Ward will become the company's ninth board member. Ward has spent more than 30 years in the medical device industry, most recently as president of...

Study backs new heart valve without cracking chest

September 22, 2010 1:36 pm | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

Thousands of older Americans who need new heart valves but are too frail to survive the surgery might soon get a chance at an easier option — a way to thread in an artificial aortic valve without cracking their chests.The aortic valve is the heart's main doorway, and a major new study found...

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FDA approves first oral drug to reduce MS relapses

September 22, 2010 6:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). (HR)

Report: Obesity hurts your wallet and your health

September 21, 2010 4:35 am | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

Obesity puts a drag on the wallet as well as health, especially for women.Doctors have long known that medical bills are higher for the obese, but that's only a portion of the real-life costs.George Washington University researchers added in things like employee sick days, lost productivity,...

Boston Scientific To Buy Asthmatx

September 20, 2010 10:43 am | News | Comments

Medical device maker will buy privately held Asthmatx Inc. in a deal that could be worth more than $440 million, the company said Monday.

FDA reviewing preliminary safety information on Actos (pioglitazone)

September 17, 2010 11:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.KJR

FDA approves devices for heart failure patients

September 16, 2010 1:45 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there...

FDA hosts Middle East and North Africa food safety experts

September 16, 2010 1:45 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration is hosting a food safety conference for regulators from countries throughout the Middle East and North Africa.

FDA , U. of Md., train Bangladeshis on aquaculture safety

September 16, 2010 1:45 pm | by U.S. Food & Drug Administration | News | Comments

Seafood safety experts from the U.S. Food and Drug Administration and the University of Maryland Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are training 10 scientists from Bangladesh on how to eliminate health hazards from aquaculture – the controlled production of...

FDA approves devices for left bundle branch block patients

September 16, 2010 10:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there...

FDA issues new dosing guide for children using Valcyte

September 15, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant. The update is intended to prevent drug overdosing...

Gov't Says Imaging Drugs Can Be Deadly

September 9, 2010 11:02 am | by Matthew Perrone, AP Business Writer | News | Comments

Regulators are warning doctors that a class of injectable drugs used in MRI scans can cause a rare and sometimes fatal condition in patients with kidney disease.

Qualcomm Now Demonstrating Products Based on LTE TDD Technology

September 8, 2010 3:45 am | by Qualcomm | News | Comments

SAN DIEGO – September 08, 2010 – Qualcomm Incorporated (NASDAQ: QCOM) today announced that the Company is on track with its commercialization of products based on LTE TDD and has been demonstrating products utilizing the technology at Expo 2010 Shanghai China. The demonstration uses the...

FDA cautions consumers about Estrella Family Creamery cheeses

September 4, 2010 3:45 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration is warning consumers to discard cheeses from Estrella Family Creamery of Montesano, Wash., because they may be contaminated with Listeria monocytogenes. Environmental samples and one product sample collected by the FDA during an August 2010 inspection...

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