From: Tull, Lori
Sent: Monday, October 31, 2011 3:27 PM
To: 'Donna Regan'
Subject: Requests for information
Our list of requests for information from today's telecon are below. Please provide by the end of November the following information, which is needed for the BLA filing.
1. Please provide a table of contents for the entire application, including the appendices.
2. Please submit your proposed prescribing information in pdf, MS Word and SPL. For requirements regarding font, format, and content, please see FDA publication ?Guidance for Industry: Labeling for Human Prescription Drug and Biological Products ? Implementing the New Content and Format Requirements? available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075082.pdf and http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Further guidance for the details of the content of each section is available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/ucm213055.htm
3. Please clarify if the maternal testing sites are CLIA certified.
4. Please include physicians? training materials and validation of the training materials for review.