Decision entries
Read a decision entry on alzheimers.ephemerisx.com, from its facts and the sponsor's request to every agency position, committee vote and source document.
Each FDA decision on an anti-amyloid antibody has its own entry page. An entry gathers what the decision rested on, what the agency said on each regulatory question, and every source document behind it.
Find an entry#
- From the home page's Decision timeline, select the drug in any row.
- From a drug's card or the command center's side panel, select a decision under FDA decisions.
- From the Ephemeris, open a drug page and select a decision, or open a row under Cases in the record.
- From any entry, use the previous and next links at the top to step through all seven in date order.
The seven entries#
| Entry | Address |
|---|---|
| Aduhelm, accelerated approval | /aduhelm-accelerated-approval/ |
| Leqembi, accelerated approval | /leqembi-accelerated-approval/ |
| Donanemab, complete response letter | /donanemab-complete-response/ |
| Leqembi, traditional approval | /leqembi-traditional-approval/ |
| Kisunla, traditional approval | /kisunla-traditional-approval/ |
| Leqembi Iqlik, subcutaneous maintenance dosing | /leqembi-iqlik-subcutaneous-maintenance/ |
| Leqembi Iqlik, subcutaneous initiation dosing | /leqembi-iqlik-subcutaneous-initiation/ |
Parts of an entry#
Header#
The label ENTRY 04 OF 07 · TRADITIONAL APPROVAL tells you where the entry sits and its pathway. Under the title, a pill says Approved or Refused.
Facts#
A row of facts, each with a small citation to the page it comes from:
- Sponsor
- Action date
- Basis for an approval (for example Study 301 (CLARITY AD): CDR-SB at 18 months), or Reason for a refusal
- Committee: meeting date and headline vote, or that it was not referred
- Confirmatory: the postmarketing requirement and its status
If some documents are not loaded yet, a Record incomplete box lists them.
What the sponsor asked the agency to accept#
The sponsor's request, as the FDA restates it, quoted from the FDA's documents.
What the agency said#
One card per position, labelled with its thread (for example T3 · ARIA), a status pill, a position ID (for example LQT-T1-1), the quote and its citation. A relation line names the earlier position it is compared to: “Compared to <id>, <decision>, <date>.”
Committee votes#
A table of every question the advisory committee voted on: Question, Yes, No, Uncertain and Source. The headline question is highlighted. If the decision was not referred to a committee, the section quotes what the FDA said about that instead.
Side column#
- Source documents: every document the entry reads, linked to fda.gov, with its page count and whether it is cited. A removed document shows No longer on fda.gov · archived copy.
- Links to other decisions: a small chart of the decisions this one is compared with, and how many comparisons there are.
- What came after: later decisions that build on this one.
Read a citation#
Citations read <Document> · PDF p. N · action of <date> · fda.gov ↗. Select fda.gov ↗ to open the source. See Reading the record and Verify a quote.