ICR Documents

Supporting Statement A Document Date Uploaded SUPPORTING STATEMENT PDUFA 4-30-13.docx 05/03/2013 Supporting Statement B Document Date Uploaded PDUFA V PROGRAM EVALUATION PART B of SS FINAL 8-13-13.docx 08/13/2013 Supplementary Documents Title Document Document Type Date Uploaded FDA PDUFA V ProgramEvaluation_Post-Action Sponsor Interview_Protocol_4-23-13 FDA PDUFA V ProgramEvaluation_Post-Action Sponsor Interview_Protocol_4-23-13.docx Supplementary Document 05/03/2013 PDUFA_V_Committment_Letter_1-12-2012 PDUFA_V_Committment_Letter_1-12-2012.pdf Supplementary Document 05/03/2013 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received Vereshchagina, Lucy PhRMA_Comments_FDA-2013-N-00931.pdf PhRMA Letter Simple 06/06/2013 06/06/2013