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U.S. Food and Drug Administration (FDA) news and information

Vital Signs
Shutdown won't stop FDA advisory meetings
By Jaimy Lee | October 07, 2013
The government shutdown isn't stopping Food and Drug Administration advisory committee meetings scheduled this month, according to drug and device manufacturers.
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Information
Pharmaceutical firms paid to attend meetings of panel that advises FDA
By Washington Post | October 07, 2013
A scientific panel that shaped the government's policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical firms seeking to affect the thinking of the FDA.
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Magazine
New drugs carry hefty price tags | Makers of leading-edge orphan products asked to cut prices, take smaller profits
By Jaimy Lee | October 05, 2013 | Print Magazine Print Magazine Subscription Details
The market for drug therapies for rare diseases is becoming increasingly crowded with expensive new products, a Modern Healthcare review of FDA approval and company pricing data shows.
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Vital Signs
Shutdown postpones House hearing on health IT regulation
By Joseph Conn | October 03, 2013
A scheduled House committee hearing on the Food and Drug Administration's progress toward implementing a federal law requiring it to develop a regulatory strategy for health information technology was postponed Thursday, as the government shutdown continued into its third day.
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News
Delays expected as result of furloughs at FDA, HRSA
By Jaimy Lee | October 01, 2013 | Basic Web Basic Web Subscription Details
The government shutdown has led to furloughs of about half of the staff at the Food and Drug Administration and the Health Resources and Services Administration and may lead to delays in the agencies' operations.
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Information
FDA approves first pre-surgical breast cancer drug
By Associated Press | September 30, 2013
A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease.
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Information
House OKs bill aimed at improving drug safety
By Associated Press | September 28, 2013
The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.
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News
Bill makes compounders' participation in oversight voluntary
By Jaimy Lee | September 26, 2013 | Basic Web Basic Web Subscription Details
A bill in Congress aimed at strengthening oversight of compounding pharmacies would make drug compounders' participation in a new regulatory category voluntary rather than mandatory.
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Information
Bill would toughen compounding pharmacy oversight
By Steve LeBlanc / Associated Press | September 26, 2013
The FDA would have greater oversight over large-volume compounding pharmacies like the company that triggered a deadly meningitis outbreak, under federal legislation winning bipartisan support.
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News
FDA to focus on regulation of smartphones, wireless devices
By Joseph Conn | September 23, 2013 | Basic Web Basic Web Subscription Details
As the number and array of health apps for mobile devices continue to explode, the federal government will keep its regulatory focus on a narrow band of products that pose the most potential risk.
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