“Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable,” says Donald DeLauder, Executive Director – Corporate Innovation, Bayer Radiology and Intervent…
Medical device manufacturing executives are currently challenged with getting products to market faster; however with increased FDA regulatory requirements and validations, they must ensure that the manufacturing processes are robust, says William J. B…
FDA has issued an alert to healthcare professionals and those suffering from multiple sclerosis. An avante garde procedure used to treat suffers of chronic cerebrospinal venous insufficiency (CCSVI), has been deemed unsafe, causing potential injury and…
Lorcaserin, an investigational obesity drug, was given a positive recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the Food and Drug Administration (FDA). The Committee voted 18 to 4 in favor, with one abstenti…
Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market – such as the antidiabetic drug Avandia and pain-reliever Vioxx – were the impetus for an Institute of Medicine committee report, recommending t…
Glioblastoma is the most prevalent and deadliest type of brain cancer, and each year around 10,000 individuals in the U.S. are diagnosed with the disease. Now, researchers have found a protein that may provide insight into how the disease moves and inv…
Levaquin (levofloxacin) has been approved by the FDA for the treatment and prevention of the plague. Levofloxacin is a synthetic antibiotic of the fluoroquinolones drug class; it is currently used for the treatment of severe bacterial infection, or inf…
Takeda says it has received a complete response letter from the FDA regarding NDAs (new drug applications) for alogliptin and fixed-dose combination alogliptin and pioglitazone – both diabetes type 2 investigational therapies. Takeda says it has recent…
A more robust postmarket drug safety program has helped improve the FDA’s (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the…
On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics The documents are available for public comment for 90 days. The agency said in a Consumer Updat…
