Mixed bag, tbh. Our proxy EUA took 12 days (!!) but another team’s been stuck for a month.
Biggest tip: Get someone in legal to pre-screen your submission. Saves so much back-and-forth.
Also, follow @FDAResponse on Twitter—they drop random updates there first.
Biggest tip: Get someone in legal to pre-screen your submission. Saves so much back-and-forth.
Also, follow @FDAResponse on Twitter—they drop random updates there first.
