fda
Response by FDA to KEI's FOIA Request Regarding the PSM India Summit of May 11, 2010 in New Delhi
Submitted by Anne Mira Guha on 19. October 2010 - 11:30In June of 2010, KEI was informed that representatives from the the United States Food and Drug Administration (FDA) had recently attended a summit in India on the issue of counterfeited and spurious medicines organized by the Partnership for Safe Medicines (PSM), a US-based organization with clear links to pharmaceutical corporate interests.
Novartis games the FDA Priority Review Voucher
Submitted by James Love on 10. April 2009 - 14:08On April 8, 2009, the FDA announced it had awarded Novartis a one-time priority review voucher (PRV) to use towards a future new drug application, for Coartem, a malaria drug. While the PRV was designed as an incentive to develop new drugs, Coartem was developed and put on the market outside the United States years before the PRV legislation was proposed.
