FDA – Page 5 – Healthy Skeptic

Jun 25 2010

The FDA and Mobile Health

By Kevin Roche Commentary No Comments

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…

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Jun 19 2010

2010 Potpourri XXII

By Kevin Roche Commentary No Comments

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…

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Jun 17 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

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.

Jun 17 2010

Washington Post

By Kevin Roche Headlines No Comments

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

May 14 2010

Bloomberg

By Kevin Roche Headlines No Comments

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

May 13 2010

Bloomberg

By Kevin Roche Headlines No Comments

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.

May 12 2010

Reuters

By Kevin Roche Headlines No Comments

Walgreen said on Tuesday it plans to start stocking gene testing kits but the FDA says it has no record that the test kit was approved or validated by the agency and plans to take a hard look at any claims made by the company

May 03 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

If the FDA does shut down the Avandia safety trial, the move would effectively be a vote of no-confidence in a drug it approved a decade ago as a safer way to control diabetes

Apr 21 2010

Bloomberg

By Kevin Roche Headlines No Comments

U.S. regulators will strengthen their oversight of medical devices used at home

Apr 21 2010

PRNewswire

By Kevin Roche Headlines No Comments

The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative

Apr 20 2010

Washington Post

By Kevin Roche Headlines No Comments

The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans

Mar 23 2010

AuntMinnie

By Kevin Roche Headlines No Comments

Apple’s iPhone med-apps excitement may be dampened somewhat with a recent FDA decision to classify an iPhone image viewing application as a class III device requiring premarket approval

Mar 16 2010

mobihealthnews

By Kevin Roche Headlines No Comments

Shortly after becoming available for download from the AppStore, MIMvista’s app was removed from the store – the reason? FDA regulation

Mar 15 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

A Food and Drug Administration panel Friday narrowly backed the use of Medtronic Inc.’s “deep-brain stimulation” device in certain epilepsy patients.

Mar 15 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

Third-party outsourcing programs have come under fire at the FDA – the agency is weighing whether to end it given questions the quality of the reviews

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