January 2020 Newsletter: Promises, Promises.
Promises, Promises. Lot’s of pressure on NYE. Our resolution is to do more of what we’ve been doing. Giving the best service possible to small and emerging drug, medical device and diagnostic companies. So “our” promise is to keep on, keeping on.
Clinical Decision Support Software Guidance
The FDA’s new draft guidance on clinical decision support software (CDS) is a major revision of a prior draft guidance issued on December 8, 2017. It explains the FDA’s method of interpreting section 520(o) of the Federal Food, Drug, and Cosmetic Act