by Caroline Fife, M.D. | Nov 10, 2015 | Fight the Good Fight, Health Information Technology and Wound Care
The FDA’s device center unveiled its regulatory science priorities for 2016. They include leveraging clinical experience, a topic touched on in the House 21st Century Cures bill. The FDA is finally making it a priority to leverage “Big Data” for regulatory...
by Caroline Fife, M.D. | Sep 7, 2015 | Cassandra Chronicles: Regulatory and Coverage Policy, Miscellaneous Musings, Pressure Cooker: Rethinking Pressure Ulcers, US Wound Registry
The drug industry, patients and consumers are urging the FDA to find better ways to integrate the patient perspective in drug development, as well as a way to use “real world” data in drug development. It will be interesting to see how the FDA reacts to the growing...
