FDA Program Seeks to Root Out Counterfeit Malaria Medication
As society becomes more and more globalized, the Food and Drug Administration is turning its eye toward improving the safety of drugs and food products all around the world. In a new report, the agency describes how they’re taking a device readily available in the United States and using it to keep citizens in Southeast… read more
Cheese Made With Raw Milk Deemed Riskier By the FDA
The Food and Drug Administration is concerned that persons who consume raw milk cheeses and other products would be in greater danger of suffering a bacterial illness. A recent study discovered that listeriosis would be 160 times more likely in soft-ripened cheese made with raw milk versus the same product made with milk that had… read more
Genotoxicity Testing Gets New Guidance From FDA
The Food and Drug Administration is offering new guidance that pharmaceutical makers will be required to follow in order to get their items approved for use. The new guidance is labeled as Genotoxicity Testing and Data Interpretation for Pharmaceuticals. It will replace two previous guidances called S2B Genotoxicity, a Standard Battery for Genotoxicity Testing of… read more
Congress Considers Bill That Extends FDA’s Foreign Inspection Power
A seeming inability of the Food and Drug Administration to properly police pharmaceutical factories in other countries has led some lawmakers to offer up a solution. A Pennsylvanian Congressman has put forth a bill that would provide critical funding to allow the FDA to conduct more inspections in drug factories abroad. The bill, known as… read more
FDA bans fewer OJ shipments for illegal fungicide
The presence of carbendazim, a fungicide prohibited by American health regulations, has prompted the United States Food and Drug Administration to prevent just three additional shipments of imported orange juice within the past month. In total the FDA has prevented 30 orange juice shipments from being imported into the United States since the government health… read more
FDA Says No Evidence Exists That Shows BPA is Dangerous
Even as studies continue to be carried out and hypotheses tested, the Food and Drug Administration has come out and said that they can find no evidence that BPA would pose a danger to humans. This issue has risen to the fore in recent months and years, with consumer advocates pointing to animal studies that… read more
Sandwich Maker Shuts Down Production Due To Health Risks
According to news sources, the Food and Drug Administration has announced that a Chicago based ready-to-eat sandwich maker has shut down manufacturing after a repeated history of violations and a reported Listeria outbreak. The company, Triple A Services Inc., has announced the closure of of the manufacturing facility after agreeing to stop producing and distributing… read more
FDA To Allow Marketing For Bleeding Skull Detection Tool
According to news sources, the Food and Drug Administration has just given approval to InfraScan Inc. of Philadelphia to begin marketing the first non invasive hand-held device to be utilized in detecting bleeding skulls. The device, named the Infrascanner Model 1000, uses near-infrared spectroscopy to help identify bleeding in the skull. Health care providers will… read more
Clinical Trials Show Pradaxa Drug Safety Concerns
According to news sources, safety concerns regarding the drug Pradaxa have led The Food and Drug Administration to caution healthcare providers about the safety of the drug after a large scale clinical trial found “serious bleeding events” related to the drug. The FDA is currently in the process of attempting to identify if the drug… read more
Untested Pelvic Mesh Highlights Concerns Over FDA Process
Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they… read more