On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and […]
Diabetes is a scourge that has prematurely taken my father and other dear members of my family. It is a disease that many others in my family deal with each and every day. We leave in fear of the devastating complications suffered by our loved ones – amputations, heart attacks, […]
On August 8, 2011, the Judicial Panel on Multi-District Litigation (JPML) announced a new MDL would be created for all of the Zimmer NexGen high-flex knee implant cases that have been filed in the federal court system. At the time the petition was filed with the JPML requesting that multi-district […]
I have spent the past 45 years hiring, firing and working with lawyers and law firms. The importance of whether you need to hire an attorney and which lawyer to hire can not be under-emphasized. Both of these decisions are important. So, when do you need an attorney and how […]
On August 2, 2011, the FDA reopened the public comment period on its proposed gluten-free labeling rule. After the 60 day comment period, the FDA will issue a final rule that defines “gluten-free” for labeling food products. The original rule was published on January 23, 2007. By establishing a standard […]
With the hottest days of summer upon us, pools and beaches are more crowded than ever. However, it is important to make sure children are properly supervised while splashing, floating and swimming. Sadly, each year more than 800 children drown in swimming pools. The risk of drowning increases during the […]
Yesterday, the FDA warned that the drug Diflucan (fluconazole) can result in rare and distinctive birth defects if taken during the first trimester of pregnancy. The FDA Safety Information and Adverse Event Reporting Program issued this safety alert to obstetricians, gynecologists, pharmacists, and infectious disease physicians, as well as the […]
Two very popular and enormously successful diabetes drugs have come under intense regulatory scrutiny over the past year. Avandia and Actos were developed and prescribed to treat type 2 diabetes. In people with type 2 diabetes the body does not make enough insulin, and the insulin that the body produces […]
Johnson & Johnson claims that its numerous product recalls last year can be attributed to poor management, staffing cuts, and integrating the consumer unit it purchased from Pfizer Inc., the company said in court papers. The report makes clear, however, that top executives are not to blame. This poses an […]
Perhaps the abysmal performance of the Toyota executives in their delay in recalling vehicles with sudden acceleration and braking problems has led to an increase in vehicle manufacturer vigilance in monitoring their own vehicles for possible safety problems. On the National Highway Traffic Safety Administration site is found the July […]
