Novartis Vaccines and Diagnostics Inc. / CMC Reviewer Laboratory / /
Event
FDA Phase / /
Facility
CMC Reviewer Laboratory of Biochemistry / /
IndustryTerm
tetravalent vaccine drug product / drug product / /
Organization
Division of Biological Standards / office of Compliance and Biologics Quality / BLA Review Committee / Food and Drug Administration / Biologics Quality / DEPARTMENT OF HEALTH AND HUMAN SERVICES / office of Compliance / Quality Control / Center for Biologics Evaluation and Research / Division of Biological Standards and Quality Control / /
Person
Muhammad Shahabuddin / Anil Choudhary / William M. McCormick / Edward Wolfgang / Silver Spring / Margaret Bash / Ramachandra Naik / /
Position
Vaccine Executive / Chair / General / Director / Executive / /
Product
Meningococcal Group B Vaccine / M3 / Recombinant Meningococcal B Vaccine / NZ vaccine / /
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]MEMORANDUM Date: