FDASIA

FDA … 20 Diseases Being Chosen for PDUFA-V Meetings

4 Comments / Action Alert, Policy / MLD Foundation / October 30, 2012 / action alert, disease meetings, FDA, FDASIA, lysosomal, lysosomal disease, PDUFA, testimony

Last Thursday, October 25th, I attended the FDA’s Patient-Focused Drug Development public meeting in Washington, DC. This meeting was required by the recently passed FDASIA/PDUFA-V legislation (see Abbreviation Decoder at end of post) and requires the FDA to hold 20 disease-specific meetings over the next 5 years to discuss topics such as: “the impact of the disease on patients,

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Report from FDA PFFD IEM meeting

FDA … 20 Diseases Being Chosen for PDUFA-V Meetings

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