| Issue Number | 5030 |
|---|---|
| Summary | [DIS] Using DAILYMED to track accelerated approval withdrawals |
| Created | 2021-09-21 16:59:30 |
| Issue Type | Task |
| Submitted By | Shields, Victoria (NIH/NCI) [E] |
| Assigned To | Kline, Bob (NIH/NCI) [C] |
| Status | Closed |
| Resolved | 2021-10-05 20:31:42 |
| Resolution | Won't Fix |
| Path | /home/bkline/backups/jira/ocecdr/issue.299222 |
We’d like to investigate whether we can use DAILYMED to keep track of accelerated approval withdrawals. Robin will attach an XML file from DAILYMED that we thought might be helpful, but it needs to be formatted so it’s more readable. We’d like to discuss this at the next CDR meeting (9/23).
I attached a sample drug label from DailyMed for the drug amoxicillin. This is labeled as an XML file, but I can't tell if there's actually some structure within the document or if it's all running text. So that's where we wanted to start so we can see if this type of information would have any utility to us.
Here's a link to their website with more information about their Structured Product Labeling (SPL) resources: https://dailymed.nlm.nih.gov/dailymed/spl-resources.cfm
I have attached a text document showing the unique paths in the XML document (with namespace stripped out, as that made it much harder to see the structure).
Thanks for the assistance in presenting this file in a readable format. Unfortunately, it doesn't look like any of these structured elements will give us the information we're looking for about drug approvals/withdrawn approvals/indications, though, so it appears we might have reached a dead end. I'm closing this issue for now.
| File Name | Posted | User |
|---|---|---|
| e8bb6e15-4912-4ab8-a5d5-4ccede21853d.xml | 2021-09-22 13:25:32 | Juthe, Robin (NIH/NCI) [E] |
| structure.txt | 2021-09-22 14:18:42 | Kline, Bob (NIH/NCI) [C] |
Elapsed: 0:00:00.002551