BioCentury on BioBusiness,
GSK's adjuvanted influenza vaccine threads novel regulatory needle in U.S.
Monday, December 3, 2012
If FDA follows the recommendation of its Vaccines and Related
Biological Products Advisory Committee, GlaxoSmithKline
plc's Q-Pan H5N1 influenza vaccine could become the first product
approved under novel regulatory pathways the agency has laid down for pandemic
However, the U.S. still would be years behind Europe, which in
2009 approved its first two pandemic vaccines - GSK's Pandemrix H1N1 and Novartis
AG's Focetria H1N1 - under a "mock-up procedure" instituted
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