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Search Results for "FDA"

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UDI piece of House health reform bill touted as saving $16B a year

Bernie Monegain October 30, 2009
The House health reform bill unveiled on Thursday includes a provision for implementing a unique device identification system that healthcare providers say could save $16 billion a year.
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States help smokers kick the habit

Patty Enrado October 07, 2009
Effective Jan. 1, 2010, Oregon insurers will be forced to cover $500 for members toward medications or quit-smoking courses.
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FDA gets social: Considers regulating social media for drugs and devices

Robin Strongin September 25, 2009
The FDA is holding a public hearing to discuss online promotion of FDA-regulated medical products – including prescription drugs, prescription biologics, and medical devices.
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Pipeline antipsychotic drugs to drive next market evolution

Industry News Release August 07, 2009
With a global value of around $22 billion in 2008 – and the leading drug class in the US – the commercial opportunity for antipsychotics is considerable. According to independent market analyst Datamonitor, the novel and reformulated pipeline atypical antipsychotics will be the engine that drives the growth potential of this developed market forward.
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Comparative Effectiveness through the Policy Lens

Glenna Crooks July 02, 2009
I don’t think we in health policy really understand how complex our systems are and what manner of challenges – some of which we created – present themselves in clinical care.
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Removing medical device preemption impacts jobs, costs of care and patient access

Industry News Release May 06, 2009
In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment
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HHS declares public health emergency for swine flu

Chelsey Ledue April 27, 2009
The Department of Health and Human Services has issued a nationwide public health emergency declaration in response to an outbreak of swine flu.
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Congressional 'Sting' Operation Uncovered By Coast IRB

Industry News Release March 12, 2009
The following is being issued by Coast IRB: In a press release issued on March 10, 2009, Coast IRB informed the public that it had discovered what appeared to be a fraudulent clinical trial submitted to that Independent review board for evaluation. Coast IRB has since learned that the fraudulent trial was apparently commenced as part of a congressional "sting" operation. Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of the FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.
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Will more over-the-counter drugs cut healthcare costs?

Richard Pizzi September 23, 2008
The cost of developing novel drugs grows annually, yet each year fewer such drugs are gaining regulatory approval. As a result, pharmaceutical companies are increasingly shifting prescription drugs to...
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