PHARMA LITERATI

Manufacturers can no longer use 28 active ingredients, including triclosan and benzethonium chloride, in over-the-counter hand sanitizers sold in the US, under a  rule  finalized by the US Food and Drug Administration on April 11. Millions of consumers rely on hand sanitizers to reduce bacteria on their hands when soap and water are not available. The FDA stopped short, however, of banning the use of three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—in hand-sanitizer products. Instead, the agency will continue to seek additional safety and effectiveness data for those three chemicals to determine whether they are generally recognized as safe and effective for use in consumer hand sanitizers. “We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, ...

The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. More than 10 million people in the U.S. have osteoporosis, which is most common in women who have gone through menopause. People with osteoporosis have weakened bones that are more likely to fracture. “Today’s approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” said Hylton V. Joffe, M.D, M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products. “But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which i...

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine. The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. Today, we’re announcing steps to consider a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms. Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. Last year, the FDA authorized an a...