Real World Data in INDs and NDAs: FDA’s Guidance Provides Little Help

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 regulatory submission containing such data. It is hard to put a good spin on this guidance because it does not give any new information that could be of much use to plan a development program using RWE derived from RWD. All this information has been published before some of it years ago. It is hard to imagine the rationale for this guidance except to increase the count of guidance documents related to this topic.