Not admitted · Vague or promotional
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 23 Nov 2024 · owen-1340
Quote
Vague or promotional
“I recommend setting standards inside the FDA regarding the timeframe for the review of these submissions. It will allow your agency to get more money, it will encourage industry to pay you for the advice before the submissions, and this will lead to less uncompensated work reviewing submitted applications.”
Open letter to Martin Makary, FDA commissioner nominee. The author recommends review-time standards for 513(g) device classification requests and predicts this will bring FDA more fee income, more industry pre-submission requests, and less uncompensated review work.
No entity, observable event, benchmark or threshold can be written from the text and its immediate context. Slogans ('game changer', 'once-in-a-lifetime opportunity', 'favourite stock') and quantifiers with no countable set ('more', 'first', 'all') without a defined set.