Get the free DAPTACEL BLA Supplement 103666/5158 Clinical Review - fda
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RAPHAEL BLA Supplement 103666/5158 Clinical Review
Page 1
Date:3/6/08From:Karen M. Mario, M.D.
Medical Officer
Vaccine Clinical Trials Branch
Division of Vaccines and Related Product Applications
Office
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What is daptacel bla supplement 1036665158?
Daptacel bla supplement 1036665158 is a supplemental application submitted to the FDA (Food and Drug Administration) for the Daptacel vaccine.
Who is required to file daptacel bla supplement 1036665158?
The pharmaceutical company or manufacturer of the Daptacel vaccine is required to file daptacel bla supplement 1036665158.
How to fill out daptacel bla supplement 1036665158?
To fill out daptacel bla supplement 1036665158, the pharmaceutical company or manufacturer needs to provide all the required information regarding the supplement, including clinical data, safety information, and any proposed labeling changes.
What is the purpose of daptacel bla supplement 1036665158?
The purpose of daptacel bla supplement 1036665158 is to request changes or updates to the existing approved labeling or manufacturing processes for the Daptacel vaccine.
What information must be reported on daptacel bla supplement 1036665158?
The information that must be reported on daptacel bla supplement 1036665158 includes any new clinical trial data, safety data, proposed labeling changes, manufacturing process updates, and any additional relevant information.
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