The Description and Ingredients information on this page is excerpted from the package inserts for each of the licensed Influenza A (H1N1) 2009 Monovalent Vaccines. Click on the below “Package Insert” links to view the complete original documentation provided by each manufacturer. INJECTIBLE VACCINES CSL LimitedInfluenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain…
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
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BK130006 Letter
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Approval History, Letters, Reviews, and Related Documents
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URGENT
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Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5
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Recall of Panoscreen lll
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Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating
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CBER-Regulated Products: Shortages and Discontinuations
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June 7, 2013 Approval Letter
DEPARTMENT OF HEALTH HUMAN SERVICES                                                     Public Health Service  We have approved your request to supplement your biologics license application for Influenza Virus Vaccine to include a quadrivalent influenza virus vaccine formulation (Fluzone® Quadrivalent) manufactured at your Swiftwater, PA facility for use in persons 6 months of age and older. The review of this product was…