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Drug Development

FDA to Hold Public Hearing on Medication Guide Program

Published in FDA Law Weekly, April 26th, 2007

The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13, 2007, to obtain feedback on FDA's Medication Guide program. Medication Guides are handouts given to patients by pharmacists each time certain prescription drugs and biological products are dispensed. Medication Guides contain FDA-approved patient information that could help prevent serious adverse events.

The goals of the public hearing include assessing the effectiveness of Medication Guides in communicating the risks of certain drug and biological products to consumers and identifying Medication Guide distribution challenges and solutions.

"We want to hear from...

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