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, […]
SaneVax Requests FDA Rescind Gardasil Approval
By: Norma Erickson 22 October 2010 On October 19, SaneVax, Inc. sent a formal letter to the FDA Commissioner requesting they rescind approval for Gardasil. Our team’s reasoning is entirely based on scientific facts described in detail in the attached letter to Dr. Hamburg. A copy of this was sent to every current member of […]
Vaccine Meeting at FDA
By: Catherine Frompovich 07 September 2010 Whenever you’re in conflict with someone, there is one factor that can make the difference between damaging your relationship and deepening it. That factor is attitude. ….William James, American Philosopher & Psychologist (1842-1910) Why in the world would I open a report about a vaccine meeting at the U.S. […]
