The cost of developing and marketing drugs and devices in the U.S. is continuing to go up as the FDA raised its annual user fees for prescription drugs, biosimilars, generics and medical devices for fiscal 2016. The increases, which go into effect Oct. 1, are based on numbers negotiated with industry as part of the five-year user fee agreements. The highest user fees are for prescription drugs and biosimilars. The 1.7 percent increase for new drug applications (NDAs) and biologic license applications (BLAs) involving clinical data for fiscal 2016 is relatively small compared with hikes in previous years. The 2016 fee is based on the FDA receiving nearly 120 full NDAs and BLAs, the average of the number of full applications submitted over the past three years.

Faced with more than 80 million genetic variants that may or may not affect a person's health or risk of disease, the FDA is realizing that it will take a village in the cloud to expand its current regulatory borders and deliver the promise of precision medicine. Known as precisionFDA, this planned community will create an environment for next-generation sequencing test developers, researchers and others to work together to test, pilot and validate new approaches, advancing the science to develop the standards and tools that will serve as the infrastructure for precision medicine. The agency hopes to open the doors to the first residents of its new cloud-based village in December.