Writing · Announcements · Notes
Writing from Brian, Flavia, and the work of building Chrona Bio. Product announcements, editorial on regulatory practice, and notes from the Commons archive as it grows.
02 — From the founders
FDA's RFI on AI-enabled early-phase trials is a signal, not a rule. What to document about AI-assisted work — ALCOA+ and Part 11 applied to a new kind of input, plus a concrete recipe for Word and SharePoint shops.
The Purolea warning letter wasn't anti-AI. It was a reminder that a tool can help create work, but a human still has to own it.
A Word add-in for the person who actually writes the IND. What it does, who it's for, and why we priced it at $99 a year.
Real IND submissions, preserved from defunct biotechs, now publicly accessible. What CTD Commons contains and how the viewer turns a folder of files into something you can actually read.
03 — Stay current
Or when a new IND lands in Commons? Brian and Flavia send updates directly to people who ask for them — no list, no newsletter platform, no marketing sequence. Reach out and we'll add you.
Talk to Brian or Flavia