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

Magazine
Making the difference | Tavenner tells Women Leaders in Healthcare attendees they can help make reform work
By Beth Kutscher | August 10, 2013 | Print Magazine Print Magazine Subscription Details
With the complicated state health insurance exchanges going live in October, CMS Administrator Marilyn Tavenner has a lot to think about at the end of the day.
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Vital Signs
Work group says OK to some HIT safety regs
By Joseph Conn | August 07, 2013
A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health IT.
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Information
FDA warns acetaminophen can cause rare skin diseases
By Wall Street Journal | August 02, 2013
The pain reliever acetaminophen, often sold as Tylenol, can cause rare but serious skin diseases, the Food and Drug Administration said Thursday.
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News
Congress should consider clarifying FDA's authority over compounding, GAO says
By Jessica Zigmond | July 31, 2013 | Basic Web Basic Web Subscription Details
Congress should think about clarifying the Food and Drug Administration's authority to oversee drug compounding, the Government Accountability Office concluded in a report released on Wednesday.
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News
Medicare offers limited coverage of Alzheimer's test
By Jaimy Lee | July 03, 2013 | Basic Web Basic Web Subscription Details
The CMS said it will not provide widespread coverage of a pricey new test that is used to identify brain plaques associated with Alzheimer's disease, but it will cover one scan per patient in limited instances.
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Magazine
Big data and big government | Strong federal role needed to organize productive use of patient data
By Merrill Goozner | June 22, 2013 | Print Magazine Print Magazine Subscription Details
The era of big data is approaching. It's hard to overestimate its potential for revolutionizing the practice of medicine.
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Information
Justice Department sues La. pharmaceutical company
By Associated Press | June 20, 2013
The Justice Department sued a Louisiana pharmaceutical company Thursday to stop it from making and distributing drugs that the government claims are misbranded and haven't been approved by regulators.
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News
FDA shifts toward informed consent for fecal transplants
By Rachel Landen | June 17, 2013 | Basic Web Basic Web Subscription Details
After tightening its regulations last month regarding fecal transplants, the FDA has decided to shift from its investigational new drug application requirements to informed consent for the procedure.
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Magazine
High-tech precautions | FDA calls for controls against cyberattacks
By Rachel Landen | June 15, 2013 | Print Magazine Print Magazine Subscription Details
With so many hospital computers and pieces of medical equipment plugged into the Internet, the healthcare system is increasingly vulnerable to intruders or malware that could crash critical components or steal information.
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News
FDA warns of cyberattacks on medical equipment, hospital networks
By Rachel Landen | June 14, 2013 | Basic Web Basic Web Subscription Details
The Food and Drug Administration issued a notice on Thursday asking medical device manufacturers and healthcare facilities to introduce controls that would guard against cyber-attacks on medical equipment and hospital networks.
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