Friday, April 29, 2011

FDA Announces Opportunity for Public Comment on Proposed Collection of Information

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The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a series of studies, Examination of Online Direct-to-Consumer Prescription Drug Promotion. These studies are designed to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug Web sites.

The open comment period began yesterday, April 28th and will last until June 27th, 2011. What do you think the results will show? Is this a step in the right direction for the regulation we've all been waiting for?

Join Lucy Rose of Lucy Rose and Associates and Peter Pitts of Porter Novelli as they use their personal experience at the FDA to interpret studies like these and give you the insight you need to develop an effective and "compliant" campaign. ePharma Summit West will be taking place July 25th - 27th in Santa Clara, California. Mention the code XP1656BLOG when registering to save 10% off of current rates.

For more information on the FDA's new initiative, click here.
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