FDA reviews and decisions
Kelsey holds FDA's approval reviews as published on Drugs@FDA[1] and quotes them by page. It also holds supplements, safety-related labeling changes, Drug Safety Communications, advisory committee material, citizen petitions, warning letters and guidance.
A review, quoted by page
For Elmiron, FDA's approval package for supplement S-014 to NDA 020193 is a 100-page PDF.[2] Labeling occupies pages 7 to 21, the medical reviews pages 22 to 37, the other reviews pages 38 to 97, and the administrative and correspondence material pages 98 to 100. Kelsey quotes a review by the page it sits on.
The document card opens the review itself: "1 Medical Officer's Review of NDA 20-193/S-014", then the dates the document lists: "NDA #20-193 Submission: 6/24/2019 Supplement 14 Submission amended: 3/24/2020 Ophthalmology Consult Submission amended: 4/24/2020". "Show the full excerpt (10,500 characters)" expands it, and "Open the document" goes to FDA's copy.
Submitted, reviewed and approved, as three dates
In the Evidence assessment, the same review gives two rows, both dated 24 Jun 2019 and tagged "Company proposed a warning": "The company's own submission of 24 Jun 2019 proposed adding a warning of retinal pigmentary changes", and a second for pigmentary maculopathy. Two other dates belong to the same supplement. The ophthalmology consult in FDA's package lists "Review completed: 5/19/2020". FDA's approval of the change is dated 16 June 2020. Each date says whether it is a submission, a review or an approval, and the type is printed beside each date.
FDA's whole record for a drug
"FDA's record for Zofran lists 886 items from 1991: 557 supplements, 274 approvals, 20 safety communications and 18 petitions." The card lists every entry that bears on a warning, and the newest of the others:
| Date | Entry |
|---|---|
| 15 Sep 2011 | FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron). |
| 29 Jun 2012 | FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran). "Archived copy, FDA page no longer online." |
| 4 Dec 2012 | FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products. |
| 28 Sep 2016 | FDA safety-related labeling change: ZOFRAN (ondansetron hydrochloride). |
When FDA has taken a page down, the card links the archived copy and says so.
Example questions
What did FDA's reviewers say about this risk at approval, and did the company later propose a warning FDA declined?
What comes back: The reviewers' passages with their page numbers, the company's submissions and FDA's response, each dated.
Which safety label changes in 2025 had no FDA safety communication?
What comes back: Each change with its date, and the label text before and after.
Sources
- FDA, "Drugs@FDA," https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA, approval package for NDA 020193, supplement S-014 (Elmiron), approval date 16 June 2020, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/020193Orig1s014.pdf