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Posts Tagged “FDA”

ShowHide 3rd Party Papers

7/29

FCC & FDA: A Memorandum of Understanding Between the Federal Communications Commission and the Food and Drug Administration Center for Devices and Radiological Health

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The FDA and Mobile Health

by Kevin Roche on Friday, June 25, 2010

An FDA lawyer posts an excellent summary of potential issues in regard to FDA’s regulation of mobile health devices and services. He suggests that industry adopt a proactive approach of proposing sensible regulations and guidance to FDA.

Tags: FDA, Mobile, Regulation, Telemedicine

2010 Potpourri XXII

by Kevin Roche on Saturday, June 19, 2010

Another weekend bonanza of health care items, including health insurance premium increases, genetic testing, remote patient monitoring, eye drug coverage by Medicare, emergency room use under the reform law and paying people to take their medicine.

Tags: Drugs, FDA, Health Insurance, Medical Care, Personalized Medicine, Telemedicine

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7/19

In briefing documents posted online, FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.

6/17

The FDA usually follows their advice. So the track records of those committees, analyzed in a new research note from Concept Capital’s Washington Research Group, are of interest.

6/17

The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines.

5/14

Gene-test kits that promise to tell consumers their risk of Alzheimer’s disease, breast cancer and numerous illnesses must be approved by regulators

5/13

Cheerios are among the foods that should be held to the same scientific standards as pharmaceuticals when promoted as having health benefits, a report ordered by U.S. regulators said today.