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Drug & Device News
FDA to Hold Public Hearing on Medication Guide Program
The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13 to gain feedback on the agency's Medication Guide program. (Medication Guides are handouts given to patients by pharmacists each time certain prescription drugs and biological products are dispensed. They contain FDA-approved patient information aimed at preventing serious adverse events.) Under current rules (21 CFR part 208), Medication Guides are required only if the drug has certain characteristics, such as a propensity to cause serious adverse health problems due to side effects or improper use. Currently, approximately 240 medications come with Medication Guides. The feedback received at the hearing will be used to assess the effectiveness of the guides and to discover and deal with their distribution challenges. For more information, please see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html.
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