Newsletter - August 6, 2015
Abuse Deterrent Technology Comes of Age in Opioid Formulation
The death toll from prescription opioids abuse has been soaring around the world over the past 20 years. It now exceeds fatalities from road accidents or deaths from heroin and cocaine in the United States, the United Kingdom and Australia according to a recent article in Nature magazine. As discussed in the article, some of the more promising approaches in the long running fight against painkiller abuse and addiction utilize ingenious pill formulations and sophisticated manufacturing technologies to render the drugs less prone to misuse, yet work as intended when taken as directed. More...
Medical Device Labeling in FDA's Cross Hair
FDA does not have a process for formal review of labels or advertisement material for approved medical device intended for patients and lay caregivers. Most Class I and several Class II devices do not require a doctor’s supervision to buy or use a given medical device. Historically, it was acceptable as most medical devices are used under supervision of a doctor and patients rely on their physician’s instructions. However, in the last decade, several devices were approved either as over-the-counter devices or required lesser physician interaction making it necessary to have labels and instructions that can be understood by those not trained in medical practice. More...
Hacking into a Remote-Controlled Medical Device is Not Science Fiction Anymore
Exactly 20 years ago, in late July 1995, Hollywood movie, The Net was released with Sandra Bullock in the lead role. The movie led to many predictions such as widely available wireless internet, interconnected information portals, even online pizza ordering (Pizza Hut and Dominos it seems like got their idea for online order from that movie). In one of the scenes, Dennis Miller’s character was killed by the villain hacking into his medical records and changing his prescription. At that time, it seemed outrageous. In his review of the movie, Roger Ebert wrote that the plot was too “concocted’ for him to care for it. More...
Abuse Deterrent Technology Comes of Age in Opioid Formulation
The death toll from prescription opioids abuse has been soaring around the world over the past 20 years. It now exceeds fatalities from road accidents or deaths from heroin and cocaine in the United States, the United Kingdom and Australia according to a recent article in Nature magazine. As discussed in the article, some of the more promising approaches in the long running fight against painkiller abuse and addiction utilize ingenious pill formulations and sophisticated manufacturing technologies to render the drugs less prone to misuse, yet work as intended when taken as directed. More...
Medical Device Labeling in FDA's Cross Hair
FDA does not have a process for formal review of labels or advertisement material for approved medical device intended for patients and lay caregivers. Most Class I and several Class II devices do not require a doctor’s supervision to buy or use a given medical device. Historically, it was acceptable as most medical devices are used under supervision of a doctor and patients rely on their physician’s instructions. However, in the last decade, several devices were approved either as over-the-counter devices or required lesser physician interaction making it necessary to have labels and instructions that can be understood by those not trained in medical practice. More...
Hacking into a Remote-Controlled Medical Device is Not Science Fiction Anymore
Exactly 20 years ago, in late July 1995, Hollywood movie, The Net was released with Sandra Bullock in the lead role. The movie led to many predictions such as widely available wireless internet, interconnected information portals, even online pizza ordering (Pizza Hut and Dominos it seems like got their idea for online order from that movie). In one of the scenes, Dennis Miller’s character was killed by the villain hacking into his medical records and changing his prescription. At that time, it seemed outrageous. In his review of the movie, Roger Ebert wrote that the plot was too “concocted’ for him to care for it. More...
