News Archives
The FDA has ordered its most serious safety warning be attached to all botulinum toxin products due to reports of serious adverse reactions and also due to risks associated with the lack of interchangeability among the three licensed botulinum toxin products. The FDA will now require manufacturers to add black box warning to labels, issue new...
Legislation introduced to give FDA more power in dealing with foreign medical device and drug manufacturers
At a time when many Americans are frustrated and outraged over safety concerns regarding imported drugs and medical devices due to grossly inadequate FDA resources and the long-standing culture of wrongdoing and cover-up amongst FDA officials, bipartisan legislation was introduced today by Senators Charles Grassley (R-Iowa) and Edward Kennedy...
GM Recalls 1.5 Million Vehicles Due to Fears of Engine Fires
According to a notice posted on April 13, 2009, on the National Highway Traffic Safety Administration website, troubled Detroit automaker GM Corp. is recalling 1.5 million vehicles equipped with 3.8 liter V6 engines due to the risk of potential engine compartment fires. The following vehicles are affected in this recall: 1997-2003 Buick...
Earlier this month, President Obama received from nine unidentified staffers at the FDA urging the president to provide all necessary support for an investigation into ongoing corruption, serious wrongdoing, and misdeeds of officials who remain in power at the Agency and create a culture of wrongdoing and cover-up. U.S. Senator Charles Grassley...
Drywall Task Force Requested by Florida Senator
Florida Senator Dave Aronberg (D-Greenacres) has asked Governor Crist to create a special task force to address the ever-growing concerns over Chinese drywall. Chinese-made drywall has been linked to seeping gases that can corrode electrical wiring, metal pipes, blacken jewelry and metal wall fixtures, and are the suspected cause of a host of...
According to a new report released this week by HealthGrades, Inc., an independent healthcare ranking company that compiles data from dozens of independent public and private sources, medical errors are still common despite the many new action plans being implemented by hospitals to safeguard against common, preventable medical errors. Researchers...
Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), said it has begun a "voluntarily" recall of the drug from the market due to serious patient safety risks following an FDA report indicating that three patients using Raptiva died of progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurological...
U.S. Senator Bill Nelson Critical of Consumer Product Safety Commission over drywall problems
In a critical letter to President Obama dated April 7, 2009, Florida Senator Bill Nelson (D-Fla.) indicated that Nancy Nord, the Chairwoman of the Consumer Product Safety Commission, should be fired for "neglect of duty" prior to the end of her term in 2012 for not acting more quickly to protect and warn consumers over defective Chinese drywall....
Today, the FDA announced that manufacturers of 25 types of Class III medical devices marketed prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976 will finally be forced to submit safety and effectiveness data to the FDA before August 7, 2009. Class III devices are those for which insufficient information exists to...
Today, Florida Governor Charlie Crist sent requests to the Environmental Protection Agency (EPA) and Centers for Disease Control and Prevention (CDC) requesting an environmental response team and industrial hygienists from the Agency for Toxic Substances and Disease Registry to help inspect homes that have suspected Chinese drywall and address the...
