FDA draws up new regulatory strategy for research, pharmaceuticals and devices
Almost 50 percent of devices and 40 percent of medications administered in the U.S. are produced outside its borders. Around 80 percent of the producers of active pharmaceutical ingredients are internationally based and the speed of global research and commerce is swiftly changing. Clearly, the regulatory framework needs to keep up. With that in mind, the FDA is setting new priorities for the coming years. An official document has been drawn up by the FDA to that effect.
“The new Strategic Priorities document sets the path for our Agency over the next four years. It establishes a framework for integrating our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship,” said FDA commissioner Margaret A. Hamburg, MD, in this report from the FDAVoice blog.