ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX), with its leading innovations in anti-cancer drug development has just announced that they have been successful in sending their ANX-530 (Exelbine) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011.
At this year’s OneMedForum SF, InHealth, the Institute for Health and Technology Studies, partnered with OneMedPlace to produce a panel discussion on improving the 510(k) process for FDA approval.
In the halls of government agencies throughout Washington, DC, plans are being made to implement reform measures that will reshape the nation’s healthcare policies—and the health of millions of Americans.
Patients hoping for a new alternative to the blockbuster blood thinner Plavix will have to wait a bit longer for a verdict on a promising candidate.
The U.S. Food and Drug Administration has approved the first implantable eye telescope to improve vision in patients with end-stage age-related macular degeneration.
Tougher FDA requirements for the drug approval process, implemented in the wake of the Vioxx disaster, have added confusion–and, according to drug companies, delays–into the mix for many pharmaceutical manufacturers. With the new requirements, drug developers may be unsure of what to file and how to file.
Copyright © 2024 | WordPress Theme by MH Themes