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 […]
U.S. FDA Grants Fast-Track Designation to Sanofli Pasteur's Investigational Clostridium difficile Vaccine
By: Sanofli Pasteur 09 November 2010 SWIFTWATER, Pennsylvania, November 9, 2010 /PRNewswire via COMTEX/ — Sanofi Pasteur, the vaccines division of sanofi-aventis Group , announced today that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to the company’s investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to […]
Watchdog Says FDA Risked Integrity
Wall Street Journal November 8, 2010 By ALICIA MUNDY WASHINGTON—Congress’s watchdog arm has criticized the Food and Drug Administration for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency. On Tuesday, a congressional committee plans to release […]
FDA Posts Gardasil Briefing Documents
Published on Friday, October 29, 2010 FDA said in briefing documents posted ahead of the Vaccines and Related Biological Products Advisory Committee meeting on Nov. 17 that data support approval of Gardasil HPV vaccine from Merck & Co. Inc. (NYSE:MRK) to prevent anal intraepithelial neoplasia (AIN) and anal cancer caused by HPV types 6, […]
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