7/29/2015 Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated
7/29/2015 Mexican food has certainly been known to wreak havoc on weak stomachs, but for some consumers of cilantro, it may be more than just the spices that has caused indigestion. The Food and Drug Administration issued an import ban on cilantro yesterday from the Mexican state of Puebla after U.S. and Mexican authorities investigated
7/28/2015 The global pharmaceutical landscape was significantly altered on Monday as Israeli drugmaker Teva announced that it will purchase the generic drug business of Dublin-based Allergan. The move will put a stranglehold on Teva’s top sales position in the generic drug market, acquiring its third-largest competitor. Teva will purchase the generics unit for $40.5 billion,
7/27/2015 In a move opposed by many food and drink manufacturers, the Food and Drug Administration (FDA) issued a proposal on Friday to requiring the industry to include detailed added sugar consumption levels in their products. The proposal is an update to the FDA’s 2014 proposed mandate requiring companies to list the amount of added
7/24/2015 The U.S. Probation Office has recommended that the former owner of Peanut Corporation of America, Stewart Parnell, be sentenced to life in prison for allowing several shipments of peanuts from facilities infected with salmonella. The peanuts led to the deadliest food outbreak in U.S. history from 2008-2009, causing nine deaths and over 700 illnesses
7/23/2015 Los Angeles Food and Drug Administration (FDA) compliance officer Dr. Raymond W. Brullo issued a scathing warning letter to Thomas Ring, the CEO of New Jersey-based device manufacturer C.R. Bard. The letter contained a litany of violations regarding several single-use devices for IVC and foreign body retrieval. The letter follows a series of inspections
7/21/2015 A facility manager for Augusta, Georgia’s Charlie Norwood VA Medical Center has been indicted on 50 counts of instructing his staff to falsify medical records for patients seeking treatment outside of the VA health system. Cathedral Henderson pleaded not-guilty to the charges in U.S District Court in Savannah on Friday. Henderson managed revenue and
7/18/2015 The Food and Drug Administration (FDA) has given the recall of Medtronic’s Shiley neonatal and pediatric tracheostomy tubes a Class I label, its most serious designation. Under a Class I label, the FDA believes that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Last
7/15/2015 Biotech manufacturer Celgene is making an earnest push to become one of the industry’s leaders following a wave of transactions aimed at increasing long-term sustainability. Celgene’s current success is largely based on the popularity of its breakthrough cancer drug, Revlimid; however Celgene is attempting to set itself up for future growth when Revlimid’s patent
The U.S. Food and Drug Administration (FDA) is joining famous environmental and consumer activist Erin Brockovich in its skepticism of Bayer’s popular birth control device, Essure. Bayer claims that the coil-like device is the only non-surgical permanent form of birth control on the market. The FDA announced last month that it will be conducting a