By: Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience … Continue reading →
By: William Maisel, M.D., M.P.H. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography—or ERCP—in … Continue reading →
By: Theresa M. Michele, M.D. With recent record snowfalls in many parts of the country, the use of sunscreens may not have been on many people’s minds. But here at FDA, sunscreens have been a front-and-center issue. On November 26, … Continue reading →
By: Gayatri R. Rao, M.D., J.D. 2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts. In recognition of Rare Disease Day, February 28th, we want to reflect on the … Continue reading →
[2-25-2015] In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. Food and Drug Administration (FDA) is requiring additional label warnings prohibiting sharing of these injectable medicines.
[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.
东北网 ... (便携式)及FibroScanTouch(触屏式)、等系列产品。在我国，FibroScan502累计销售已超过300台，95%的用户为三级甲等医院。在美国，FibroScan于2013年4月获 FDA认证 并批准上市，目前虽处于美国市场培育期，但销售前景正 ... and more »
