FDA report on narcolepsy public meeting is released
The U.S. Food and Drug administration (FDA) has released its final report on the public meeting on narcolepsy. Â “The Voice of the Patient” summarizes comments and themes that PWNs and their supporters offered at the Sept. 24, 2013 public meeting and via the public docket, which was open for comment for several months in the fall of 2013. Â The meeting, and the newly released report are part of the FDA’s Patient-Focused Drug Development Initiative.
The patient perspectives gathered at theÂ meeting and inÂ the docket haveÂ strengthened FDA’s understanding of the burden that narcolepsy has on patients, as well as methodsÂ PWNs use to manage their symptoms, and anyÂ side effects they may experience as a result of those treatment methods. Â The FDA staff will consider these findingsÂ when they are evaluating newÂ products under review for marketing approval.
See the full report on the FDA’s website.
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Date Created: June 26th, 2014
Last Updated: June 26th, 2014