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A Review of Patient Reported Outcome Labels in the U.S. - 2006-2013

March 24, 2015

Recorded Live May 15, 2014

Analysis of PRO Evidence for Orphan Drug Label Claims

In this webinar, we go over background information on orphan drugs, priority and standard reviews,  PROs in rare diseases. Then, we analyze the results from reviewing product labels and drug approval packages (DAPs) for orphan drugs from January 2006. Our guest speaker is Ari Gnanasakthy.

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Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions o...

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COAs and Regulatory Labeling Claims: Information and Limitations
COAs and Regulatory Labeling Claims: Information and Limitations

<p>Recorded Live December 12, 2013</p>