FDA認證 聯合新聞網 興櫃新藥股國鼎生技(4132)宣布，旗下的新藥Antroquinonol日前已通過美國食品暨藥物管理局(FDA)認定為治療胰臟癌的孤兒藥，除可獲得美國研究經費補助外，藥物主管機關更給予行政協助及市場專賣保護期等優惠措施。該公司表示，未來新藥獲得上市許可後，將 ... and more »
By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or … Continue reading →
By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. The world was a very different place in 1976, when the Food and Drug Administration launched its medical device program. Since Steve Jobs and Steve Wozniak were just that year launching a … Continue reading →
By: Margaret A. Hamburg, M.D. FDA is weighing the appropriate regulatory approach to advances in technology that allow physicians to obtain information on large segments of a patient’s genetic makeup very quickly. This technology is known as next generation sequencing, … Continue reading →
By: Margaret A. Hamburg, M.D. FDA oversees products that represent more than 20 cents of every dollar that American consumers spend. Today, FDA presented its FY 2016 budget to Congress.This sensible budget request will help ensure that FDA can continue … Continue reading →
By: Michael R. Taylor Over the past two years, my colleagues and I have written here about what FDA is doing to create the preventive, risk-based food safety system mandated by the FDA Food Safety Modernization Act (FSMA). We’ve taken … Continue reading →
