But FDA Says Early Reports of Seizures Does Not Mean Vaccine is Unsafe By Daniel J. DeNoon, WebMD Health News Jan. 20, 2011 — The FDA and CDC are investigating reports linking febrile seizure in infants to the Sanofi Fluzone flu vaccine. The reports come from the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). It’s […]
January 13, 2011 FDA Approval Letter – Cervarix
Our STN: BL 125259/112 GlaxoSmithKline Biologicals Attention: Matthew Whitman 2301 Renaissance Boulevard P.O. Box 61540 King of Prussia, PA 19406-2772 Dear Mr. Whitman: We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to include a Patient Package Insert to the full prescribing information. […]
FDA Panel Votes to Approve Second HPV Vaccine
Posted by: admin in ‘Pharmacy Drugs’ 16 October 2010 WASHINGTON – An FDA advisory panel today voted to recommend approval of GlaxoSmithKline‘s Cervarix vaccine for use against the two strains of human papillomavirus (HPV) that cause 70% of cervical cancers. In a separate action, the Vaccines and Related Biologics Committee recommended that the agency okay […]
Under Fire FDA's Top Cop Steps Down
By: Vera Hassner Sharav 30 November 2010 “The thought that someone at the GAO may have compromised the testing of a system unfortunately, brings the integrity of the entire report into question if it’s determined to be true.” Sen. Charles Grassley. On November 23, 2010, Terry Vermillion, Director of FDA’s Office of Criminal Investigation […]
FDA advisory backs Merck & Co's Gardasil for prevention of anal cancer and AIN in both men and women
Posted in ‘thepharmaletter.com’ 19 November 2010 The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for drug giant Merck & Co’s (NYSE: MRK) Gardasil ([Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant) for the prevention of anal cancer and […]
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