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What's New: Biologics
Sep 08
Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010
Sep 07
Sep 07
Package Insert Updated December 2009 to include additional adverse events.
Sep 03
Sep 03
clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009
Sep 02
a prefilled syringe which has a tip cap which may contain natural rubber latex and plunger which does not contain latex
Sep 02
Sep 01
Revised the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
Aug 31
to revise the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
Aug 30
Aug 26
Influenza Virus Vaccine, Fluvirin®, to revise the Package Insert to include the appropriate warnings regarding natural rubber latex containing components in the tip caps of the pre-filled syringes.
Aug 25
For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.
Aug 24
URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation
Aug 17
Clarification to your approval letter of October 19, 2009, regarding the pediatric study.
Aug 12
Information updated through July 31, 2010
Aug 12
Information updated through July 31, 2010
Aug 12
Information updated through July 31, 2010
Aug 10
Recall of Panoscreen lll
What's New: Biologics