ICU

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  • 04/28/2010

During her April 22 presentation to the Food and Drug Law Institute's annual meeting, Woodcock was asked when FDA would translate its commitment to the idea of transparency into a greater number of concrete actions. "The answer, honestly, is I don't know," she said. "These things all take time and resources, dedication ... So I can't actually tell you."

FDA's transparency initiative has three components: providing information to the public via a website about what the agency does; deciding what types of information can be disclosed (for example about new safety issues or product applications), and being more transparent to industry about its processes.

Some stakeholders have called on the agency to take transparency into newer areas, such as releasing product application "complete response" letters.

Dealing with documents is not as simple as posting them on the FDA website, it appears. Woodcock said nearly all of them would require some redacting of proprietary or other sensitive information for legal protection. She said when the number of pages reaches into the billions, it is a massive workload.

Transparency – terrific.  But how do we want to FDA to spend its resources?

On a entirely different subject, this just in from the BBC:

Men whose love lives are falling short can try a new prescription pill to combat the problem.

The first drug made available in the UK for premature ejaculation, called Priligy, can reportedly triple the amount of time a man can last in bed. It works by altering levels of serotonin in the brain, which should give men more control over ejaculation.

Keep calm and carry on.

The complete Beeb story can be found here: 
http://news.bbc.co.uk/2/hi/health/8646075.stm

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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