Food and Drug Administration (FDA)

See the following -

Big Pharma's Last Refuge

Bill Frezza | Bio IT World | September 27, 2011

In the previous issue of Bio•IT World (July/August 2011), my fellow columnist Ernie Bush posed the question, what are the limits to collaboration among pharmaceutical companies? This same question was faced by the telecommunications industry in 1913, albeit during an era of ascendancy and not senescence. This led to a solution that lasted 70 years. Could history repeat itself? Read More »

Big Sugar's Sweet Little Lies

Gary Taubes and Cristin Kearns Couzens | Mother Jones | November 1, 2012

How the industry kept scientists from asking: Does sugar kill? Read More »

Bipartisan Policy Center's Health Innovation Initiative: Health IT Industry Officials Lying To Regulators With Impunity?

InformaticsMD | Health Care Renewal | February 14, 2013

A statement that health IT has a "lower risk profile" compared to other regulated healthcare sectors such as devices or drugs, in order to seek continued and extraordinary regulatory accommodations, is remarkable.  It is either reckless regarding something that the statement's makers should know, or should have made it their business to know - or a deliberate prevarication with forethought.

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Bloomberg Health Care Summit on "Connecting Healthcare Policy with Next Century Innovation"

Earlier this week, the Bloomberg Government Health Care Summit appropriately named "Mind the Gap: Connecting Healthcare Policy with Next Century Innovation", was held in Washington, D.C. It was convened to discuss perspectives of healthcare innovators, medical professionals, and government officials who are helping to redesign U.S. healthcare during a time of innovation. About 150 healthcare industry representatives were in attendance. One of our Open Health News (OHN) correspondents was there. Read More »

Bracing For A Battle, Vermont Passes GMO Labeling Bill

Eliza Barclay and Jeremy Bernfeld | The Salt | April 24, 2014

The Green Mountain State is poised to become the first to require food companies to label products containing genetically modified ingredients. Read More »

Breaking the Seal on Drug Research

Katie Thomas | New York Times | June 29, 2013

Together with a band of far-flung researchers and activists, [Dr. Peter Doshi] is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public. Read More »

Breeding Bacteria On Factory Farms

Mark Bittman | New York Times | July 9, 2013

The story of antibiotic-resistant bacteria in farm animals is not a simple one. But here’s the pitch version: Yet another study has reinforced the idea that keeping animals in confinement and feeding them antibiotics prophylactically breeds varieties of bacteria that cause disease in humans, disease that may not readily be treated by antibiotics... Read More »

Can Doctors Teach The Body To Cure Cancer?

Jacoba Urist | The Atlantic | July 28, 2014

Increasingly, doctors are using their patients' own immune systems as valuable weapons against the disease...

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Can The Feds Make Health IT Systems Talk To Each Other?

Kenneth Corbin | CIO | February 7, 2014

Government officials are reluctant to issue mandates on standards and interoperability for health IT devices and applications -- but advocates say that's exactly what healthcare needs to promote innovation and improve patient care. Read More »

Cantaloupe vs. al-Qaeda: What's More Dangerous?

Michael Meurer | Truthout | September 15, 2013

[An important revelation] is the exposure of a nearly lunatic disproportion in threat assessment and spending by the US government. This disproportion has been spawned by a fear-based politics of terror that mandates unlimited money and media attention for even the most tendentious terrorism threats, while lethal domestic risks such as contaminated food from our industrialized agribusiness system are all but ignored Read More »

CDC Official Protests Federal Medical Response Cuts

Diane Barnes | Nextgov.com | April 29, 2014

More than half a decade of reductions to spending on state and local public-health agencies has already been "extremely damaging" to capabilities across the country for responding to unconventional attacks and other disasters, Dr. Ali Khan, director of the Public Health Preparedness and Response Office at the Centers for Disease Control and Prevention, told Global Security Newswire in an interview. 

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CDC Threat Report: Yes, Agricultural Antibiotics Play A Role In Drug Resistance

Maryn McKenna | Wired | September 17, 2013

The grave assessment on the advance of drug resistance, released Monday by the US Centers for Disease Control and Prevention, contained some important observations about the relationship between antibiotic use in agriculture and resistant infections in humans. [...] Read More »

CDC Threat Report: ‘We Will Soon Be In A Post-Antibiotic Era’

Maryn McKenna | Wired | September 16, 2013

The U.S. Centers for Disease Control and Prevention has just published a first-of-its-kind assessment of the threat the country faces from antibiotic-resistant organisms, ranking them by the number of illnesses and deaths they cause each year and outlining urgent steps that need to be taken to roll back the trend. Read More »

CDC Unable To Conduct Lab, Detection Work On Salmonella Outbreak

Tom Sullivan | Government Health IT | October 9, 2013

For all those Americans crossing fingers that no communicable disease, influenza or foodborne illness outbreaks would happen during the government shutdown, exactly that has occurred. Read More »

CDISC and TransCelerate Announce New Standard for Breast Cancer to Support Data Sharing for Oncology Research

Press Release | CDISC, TransCelerate BioPharma, Inc. | May 18, 2016

The need to rapidly and efficiently share new data in cancer research was recently, and powerfully, highlighted by U.S. Vice President Joe Biden as part of the Cancer Moonshot initiative. The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma, Inc. (“TransCelerate”) announce today the open availability of a new CDISC Therapeutic Area (TA) Standard for Breast Cancer. The CDISC global TA standards can streamline the way clinical research is conducted so that data can be readily shared among clinicians, researchers and regulators around the world, thus leading to more rapid and “smarter” research...

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