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Feb 5, 2015, 10:40
by
Michael Croft
Clinical Informatics News | The White House will announce tomorrow that Margaret Hamburg, Commissioner of the Food and Drug Administration since 2009, is stepping down. Hamburg has led the agency through hugely consequential changes to its powers and regulatory authority over one of the longest terms as commissioner in FDA history.
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Feb 3, 2015, 10:40
by
Michael Croft
Clinical Informatics News | News and product releases from around the industry, including new analysis technology for Sequenom's non-invasive prenatal tests and Oracle's automated medication adherence tracker.
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Jan 30, 2015, 00:00
by
Michael Croft
New England Journal of Medicine | Francis Collins
and Harold Varmus discuss the President's Personalized Medicine
Initiative.
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Jan 28, 2015, 12:30
by
Michael Croft
Clinical Informatics News Brief | The House Committee on Commerce and Energy has published a draft version of the 21st Century Cures Act, a sweeping bill containing numerous changes to the FDA's powers to review and approve drugs and medical devices.
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Jan 28, 2015, 12:00
by
Michael Croft
Clinical Informatics News Brief | This week the Truveris National Drug Index released its first full year figures. In 2014, generic and specialty drugs combined rising 10.9%. Brand drug prices spiked 14.8%, while specialty drug prices jumped 9.7%. Generics, historically intended to curb costs, are contributing to prescription price inflation, increasing 4.9% last year.
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Jan 27, 2015, 10:10
by
Michael Croft
Clinical Informatics News | As the Department of Defense considers bids to replace its legacy EHR system with a modernized solution, it stands to create the nation's largest interconnected health IT system. That could have big repercussions for the future of EHR interoperability, population health, and coordinated care in the military and across the country.
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Jan 27, 2015, 00:00
by
Michael Croft
CHAPEL HILL, NC, UNITED STATES - Jan 27, 2015 -
WHAT: Rho, a full-service contract research
organization (CRO), will highlight its continued success in drug
development strategies and services during the Outsourcing in
Clinical Trials (OCT) West Coast conference, being held February
3-4 in Burlingame, California
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Jan 26, 2015, 15:35
by
Michael Croft
Clinical Informatics News Brief | Secretary of Health and Human Services Sylvia Mathews Burwell today published a letter in the New England Journal of Medicine outlining near-term goals for influencing the direction of U.S. healthcare.
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Jan 26, 2015, 10:00
by
Michael Croft
Clinical Informatics News Brief | PHT Corporation is expanding its rater training program that it first launched in November.
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Jan 26, 2015, 00:00
by
Michael Croft
WSJ | A bill was introduced in Congress last week
that is designed to alleviate frustration drug makers have felt
over a recent FDA guidance concerning fixed-dose combination drugs.
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Jan 26, 2015, 00:00
by
Michael Croft
BOSTON, MA, UNITED STATES - Jan 26, 2015 - The pharmaceutical industry is further optimizing the collection of high quality electronic patient reported outcomes (ePROs) data for clinical research, with PHT CorporationRater Training programs
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Jan 26, 2015, 00:00
by
Michael Croft
WARSAW, POLAND - Jan 26, 2015 - KCR, a Contract Research Organization (CRO) operating across 19 European countries and in the U.S., is developing an innovative clinical trial data platform based on the Clincase electronic data capture (EDC) and clinical data management (CDM) software delivered by Quadratek Data Service
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Jan 23, 2015, 00:00
by
Michael Croft
WSJ | European regulators recommend suspending the
sale of hundreds of drugs that were authorized for use across the
continent based on "flawed" clinical studies that were conducted by
GVK Biosciences, a clinical research organization based in India.
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Jan 22, 2015, 12:00
by
Michael Croft
Clinical Informatics News | GenoSpace announced this morning that Michelle Munson, CEO of Aspera, an IBM Company, has joined its board as an independent director.
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Jan 22, 2015, 00:00
by
Michael Croft
Modern Healthcare | Ten years ago, President
George W. Bush briefly mentioned electronic health records in a
State of the Union address and the federal government is now in the
midst of a multibillion dollar effort to promote the technology.
Can the same thing happen with cybersecurity?
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Jan 21, 2015, 15:00
by
Michael Croft
Clinical Informatics News | QIAGEN’s circulating tumor DNA companion diagnostic for lung cancer has been granted CE-IVD marking in 30 European countries, the company announced. The diagnostic is designed as a companion for Astra Zeneca’s IRESSA for non-small cell lung cancer patients.
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Jan 21, 2015, 00:00
by
Michael Croft
Healthcare IT News | In the latest example of a
world-class health system yanking its established electronic health
record in favor of a blue chip vendor, Mayo Clinic is migrating to
Epic.
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Jan 21, 2015, 00:00
by
Michael Croft
WSJ | Ida Sim, a professor of medicine and at the
University of California, San Francisco and a member of an
Institute of Medicine committee, discusses a new IOM report on
sharing clinical trial data.
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Jan 20, 2015, 11:00
by
Michael Croft
MobiHealthNews | FDA has published a draft guidance to help wellness device and app makers more clearly understand which products are subject to FDA regulation and which are not.
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Jan 20, 2015, 10:00
by
Michael Croft
Clinical Informatics News | Contributed Commentary | Clinical trial design has become more complex and the demands of the regulators ever more stringent, but clinical automation tools can make life easier on both counts. Clinical automation is a centralised software tool implemented within a clinical unit that supports volunteer recruitment, automates workflow through an electronic trial design schedule, drives operations at the clinical floor, and enables study data to be captured electronically (eSource), streamlining the clinical process. It also enables high quality data to be shared online, in real time, with the sponsor.
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