[mft_]

> This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.

That would be nice, but my experience is there can be quite significant variability between reviewers in different teams/groups, even on topics you'd think were well-established for many years, and for which there is existing FDA guidance.

[hnthrowawayacct]

I’m currently arguing a statistical plan for a neurostim phase two clinical trial IDE submission with the FDA. We got some borderline reckless comments back that are massively out of line with correspondence on previous pivotal submissions. It’s starting to look like some of the reviewers are taking on work outside the scope of their expertise. Really disappointing to see, especially with the new more streamlined MDR reqs coming out of the EU.

[mft_]

Sounds familiar.

Despite working to enforce laws and guidelines --i.e. somewhat similar to a court sitting in judgement on a case-- there's apparently no expectation of consistency, there's no concept of 'case law' (i.e. you applied logic in this way before, so we have the right to expect that you apply it the same next time) which can be relied upon, and maybe worst of all, there's no route to challenge or appeal when bad judgements are handed down.