Day: May 9, 2019

A very short 4-page Guidance Document from FDA Guidance Document gives little, if any. It defines Real World Data (RWD) and Real World Evidence (RWE), and states that both RWE/RWD can be used to support INDs and NDAs. It also provides some examples of such use, along with checklist for the cover letter of a … Read more

This week FDA released a “new” guidance about medical device meetings which is rehash of old advice with several tips to make these meetings productive. It can be argued that there are few, in any, new proposals in this guidance but it is still a useful read for the industry. FDA meetings are an excellent … Read more