Janet Woodcock ran drug regulation itself for three decades

Who this is

longtime CDER director; acting FDA commissioner, 2021. In Jonathan Hare's account (S-192), he and Jack Lewin met numerous times with almost every FDA commissioner of the era, and Janet Woodcock is on that list. This page is deliberately thin: it exists so the archive-miner pass over Hare's email can attach the dates, rooms and substance. Their account is invited meanwhile.

The public record, at web grade. The physician who directed the FDA's Center for Drug Evaluation and Research for most of three decades — the modernization of review, Critical Path, and Operation Warp Speed's therapeutics all ran through her — acting commissioner in 2021 and principal deputy commissioner until her retirement in 2024. Institutional memory of American drug regulation, in one person. In this record's network: CDER is the first of the three division chairs named in Hare's account of the Lewin-era meetings (S-192), and any FDA-wide data effort — the Seyfert-Margolis pilot included — lived or died by her center's participation.

Connected from here

There is no single root. This is one view of the graph, from this node — what you see depends on where you enter and what you are looking for.

Where this came from

Everything above is a distillation. The primary source is published in full, so that any claim on this page can be walked back to what was actually said — and where the two differ, the source governs.

What is missing, and how to fix it

This entry is deliberately incomplete. The gaps below are the things only certain people can settle — and settling one is a contribution like any other: recorded, timestamped and attributed to whoever made it.

• The meetings, from the email archive