When the monoclonal biological ADUHELM got accelerated approval on June 7, 2021, I provided a set of links to the higher than typical number of documents the FDA released - original blog here.
Two weeks later, on June 22, the FDA released an additional 100 pages, in 3 PDFs, of memos, data analyses, and rationales for the approval. Stories on this topic ran in Stat and Reuters, but it was hard to find the original links. I've added the new documents as an update to the June 7 blog and I'm also posting the links here.
- On June 22, 2021, FDA released one 80-page PDF and two shorter PDFs about the ADU review process at FDA.
- Stories highlighted this at Stat and Reuters, and USNews, but didn't link to the documents.
- Find the new documents at the FDA home page for ADU, in the lower right, under "FDA Application Review Files."