FDA Updating Prescription Drug Use During Pregnancy, Breast-Feeding
FDA proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding. Read more
FDA Requests Recall Of Xiadafil VIP Tabs
FDA requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure Read more
FDA Approves Entereg For Bowel Function Following Surgery
FDA approved Entereg (alvimopan) to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Read more
Improving Medical Products For Patient Safety
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Read more
FDA Will Monitor Medical Records Of Medicare Beneficiaries
HHS on Thursday announced the creation of a new program that will allow FDA, state agencies and academic researchers to use medical record data to ensure drugs and medical devices are safe for consumers after they enter the market, the Washington Post reports (Stein, Washington Post, 5/23). Read more
FDA Medicare Alliance To Tackle Drug Side Effect Problems
Starting from the next month Food and Drug Administration (FDA) and Medicare will cooperate on launching a new program, which will help in monitoring safety problems of drugs and medical devices that are already in the U.S. prescription drug market. Read more
Adding Up A Balanced Diet
It’s important to choose foods wisely in order to eat a healthy, balanced diet. But how? The Food and Drug Administration (FDA) offers help. And it’s right on the packages! Read more
Naturlose Readily Accepted By Diabetes Patients
Naturlose, a natural sugar approved as a food ingredient in US and abroad, has been found to reduce the spikes of serum glucose that follow consumption of food. In a Phase 3 human clinical trial, Spherix is currently studying the efficacy and safety of Naturlose for the treatment of diabetes. Read more