Latest FDA Stories
Lawrence LeBlond for redOrbit.com - Your Universe Online Purdue Pharma’s OxyContin, a name-branded narcotic pain killer using the oxycodone formula, has long been a source of abuse for addicts. In a move to reduce that risk of abuse, Purdue in 2010 developed reformulated OxyContin tablets that would make it difficult for abusers to get a high off the drug. But as the patent was set to expire this week on the original OxyContin formula, addicts everywhere could soon have a new avenue...
Trial Expands to Two Centers; Approval Includes Significant Increase in Dosing ROCKVILLE, Md., April 17, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers,...
TAMPA, Fla., April 16, 2013 /PRNewswire/ -- ISPE announced today that it will hold its second annual Redefining the "C" in CGMP conference, 11 - 13 June in Baltimore, Maryland USA. Themed "Ensuring a Reliable Supply of Quality Medicines," the event will feature strategic education on issues of interest to industry leaders and global regulatory officials focused on quality systems, processes and technology utilization that drive quality enhancements that support a reliable drug...
PLSG Portfolio Company Receives FDA Authorization to Market The Stork(TM), Opens Headquarters and Launches Commerce Website PITTSBURGH, April 16, 2013 /PRNewswire/ -- Rinovum Women's Health, a privately held women's health company dedicated to bringing products into the market that will enhance women's lives and empower them to take charge of their health, announced today that it has expanded staff, moved to its new Pittsburgh headquarters and launched its online presence as part of...
CHARLESTON, S.C., April 16, 2013 /PRNewswire/ -- Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today the U.S. Food and Drug Administration has granted its request for a Pre-IND meeting to discuss the proposed Investigational New Drug, CL-H1T, as a novel...
Michael Harper for redOrbit.com – Your Universe Online Last week the US Food and Drug Administration (FDA) issued a public warning about the stimulant dimethylamylamine, or DMAA. This comes after several medical researchers have discovered that the stimulant could lead to heart attacks or, in the case of two American soldiers, even death. DMAA is marketed by its manufacturers as a fat-burning, muscle-building stimulant that enhances performance in weight lifting and other sports....
Names Paul LaViolette as Executive Chairman and Renny Clark as Chief Financial Officer MARLBOROUGH, Mass., April 16, 2013 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announced today that it has expanded its management team. Paul LaViolette, previously Chairman of the Board, has been named Executive Chairman and Renny Clark has been named Chief Financial Officer and Treasurer. They will work...
WASHINGTON, April 15, 2013 /PRNewswire/ -- PharMEDium appreciates Congress' efforts to reexamine oversight of pharmacy compounding in the wake of the deadly meningitis outbreak. PharMEDium provides a valuable service on which hospitalized patients depend and feels strongly that oversight of the compounding pharmacy industry is in need of reform. Today, the safety of patients depends on the patchwork of ambiguous federal jurisdiction and inconsistent state regulatory approaches. For...
Trial is the first to be initiated in FDA pilot program for U.S.-based first-in-human trials CHARLOTTE, N.C., April 15, 2013 /PRNewswire-USNewswire/ -- Carolinas HealthCare System's Sanger Heart & Vascular Institute became the first in the world to implant a branched stent graft specifically designed for branch vessel repair of thoracic aortic aneurysms on Thursday. This is the first arch graft available in a clinical trial and both the device and surgical approach are novel....
WARRINGTON, Pa., April 15, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the U.S. Food and Drug Administration (FDA) has requested clarification and provided recommendations regarding the recently-updated product specifications for SURFAXIN(®). Discovery Labs plans to provide a response to the FDA within two months. FDA procedure provides up...
