At the mHealth Summit taking place in Washington, D.C. this week, a panel discussion on mobile health and pharmaceutical companies talked about how companies are using mHealth in developing nations, particularly for their supply chains.Susan Shiff of Pfizer (NYSE:PFE) focused on how the pharmaceutical company was developing an epidemiological database with Lagos University Teaching Hospital [...]

A new survey critical of the U.S. Food and Drug Administration’s 510(k) review process makes important suggestions for improvement, but is not representative of the industry as a whole.That was the response of Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who participated in a panel Tuesday to discuss results of [...]

The medical device industry approaches with caution as the first major payment reforms of the Affordable Care Act are released by the Centers for Medicare and Medicaid Services.The Centers for Medicare & Medicaid Services introduced a proposal to change the way hospitals are paid as part of President Barack Obama’s landmark health care reform law.The [...]

At-home genetic testing may have too many false results for U.S. Food and Drug Administration regulators. Plus, with these tests, the FDA says, patients get results for serious medical issues without consulting a physician.

A federal judge in Washington, D.C., tosses a constitutional challenge to the Patient Protection & Affordable Care Act, moving the score to 3-2 in favor of the landmark healthcare reform law.

The federal watchdog agency is pitching Congress and President Barack Obama for $4.3 billion for fiscal 2012, about a third more than it got in 2010. The FDA’s fiscal 2011 request was for $4.03 billion, a 23 percent increase over 2010.

The Food & Drug Administration, aiming to blaze trail on a so-called “Innovation Pathway” designed to speed innovative medical technology to market, tapped a military project to create a prosthetic arm controlled by a brain-implanted microchip as its first speedy review candidate.

Twenty Republican governors send Dept. of Health & Human Services chief Kathleen Sebelius a letter asking for control over the health insurance exchanges mandated by the Patient Protection & Affordable Care Act.

Is Europe’s approach to regulating new innovative medical devices better than the U.S. Food and Drug Administration’s? Industry leaders in the United States are touting a new report that says there’s no safety differences in the United States and Europe.

A federal appeals court upheld a lower court’s dismissal of a lawsuit filed on behalf of all frozen human embryos in the U.S. that sought to halt federal funding of research using stem cells derived from the embryos.