Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”.
Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press
Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled. This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies
A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014).
The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition
Though the diet supplement OxyElite Pro was recalled last year due to a connection with liver damage and acute liver failure, more people continue to get sick, according to a recent report by Scientific American.
Currently, at least 97 people have suffered severe hepatitis in connection with OxyElite Pro, and one person has died.
A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced. The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and
In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry.
To that end, Congress passed the Drug
Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention.
While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the
A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia. Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug. The U.S. Food and
Salmonella is a food-borne bacteria, typically present in meat and poultry products. An estimated 1.3 million illnesses can be attributed to Salmonella every year. To address outbreaks of salmonella, the US Department of Agriculture’s (USDA) Food and Safety Inspection Service (FSIS) has released its Salmonella Action Plan that outlines the steps it will take to
Ellen Beck recently wrote an article for the “Smart Blog on Food and Beverage” website titled “FBI Makes Threats to U.S. Food Supply a Bigger Priority”, that discusses the food industry’s vulnerability to intentional food contamination. In light of all the terrorist attacks taking place throughout the world, the FBI is becoming increasingly