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Vaccines

Committee Memo Clinical Review Signatory Authority, November 20, 2012 - Flucelvax

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


 

                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

To:                                          The File of STN 125408/0
Date:                                      November 20, 2012
 
STN #:                                    125408/0
Supplement Type:                  Biologics License Application Original Submission
Sponsor:                                  Novartis Vaccines and Diagnostics GmbH
Product:                                  FLUCELVAX, Influenza Virus Vaccine
 
Clinical Branch Chief:           Jeff Roberts, M.D.
Signature:                  
  
Due to ---------------------(b)(6)---------, the Clinical Reviewer (Melisse Baylor, M.D.) of the Flucelvax file STN 125408/0 was unable to place her approval stamp on the final clinical review memorandum. Dr. Baylor and I have discussed and agreed upon the substantive content of her review. Dr. Baylor provided to the review team via email on November 19, 2012, the final version of her memorandum. I reviewed this version in detail, and I concur with its content and conclusions. Therefore, I made no changes to the final version provided by Dr. Baylor before converting to PDF and placing my approval stamp. The Team Leader on the file, Dr. Lucia Lee, also concurs with the content and conclusions of the review. Dr. Lee has agreed to provide her approval stamp in place of Dr. Baylor. This memo is to document sole authorship on the part of Dr. Baylor along with concurrence with the content and conclusions of the clinical review on the part of me and Dr. Lee.