Questions tagged [openfda]
Questions and answers surrounding the U.S. Food and Drug Administration's OpenFDA program.
261
questions
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Why is my API call for application_number is not working?
#1: https://api.fda.gov/drug/event.json?search=patient.drug.openfda.application_number:ANDA076407
I am trying to make a similar API call to above but for below application#
New Drug Application (NDA): ...
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1answer
16 views
FDA Press Releases/Announcements
I am looking at the openFDA documentation and I don't see an endpoint to gather all of their press releases/announcements. Can I back into that using the existing api?
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1answer
39 views
Given the 510k dataset, how do I derive the location of summary PDFs?
Having ingested the 510k dataset, several of the entries have a statement_or_summary value of "Summary" or "Statement" which I understand means a summary/statement is available.
...
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1answer
15 views
Error retreiving adverse event by country
I was using a query like this one https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct.exact:("ELIQUIS")+AND+receivedate:[20110101+TO+20151231]%27+AND+occurcountry:%27fr%...
1
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1answer
32 views
is there a way to fetch only the updated documents in openFDA?
I am using a query like the following one
https://api.fda.gov/drug/label.json?search=effective_time:[20110601+TO+20121231]&limit=1
to search for all records with effective_time between Jun 01, ...
1
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1answer
41 views
Getting newly approved drugs from any of the Drug API Endpoints
I am looking to build and maintain a database of newly approved oncology drugs from the FDA.
I need something similar to their "What's new" or "Novel Drug Approvals" section on ...
1
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1answer
15 views
Question RE Safety Report ID
I'm seeing the following in the drug event endpoint:
On a "conceptual" level, it would appear that these are the same person, however, they appear in the drug event endpoint repeatedly, so ...
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2answers
17 views
How to inquire about adverse events of aspirin in the open FDA？
I want to check the adverse events of aspirin drugs in the open fda data within the specified date
I have tried many times and it keeps getting an error display
Where did I go wrong ？ How can I query ...
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0answers
14 views
Local instance setup instructions
I'd like step by step instructions for setting up OpenFDA in my lab.
The goal is to have the available pipelines populate and update the data in Elasticsearch so that I can make use of Kibana for ...
1
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1answer
16 views
Question about total number of drug adverse event reports from 1998-2004
Is there a reason why from 1998-2003 the total number of reports in the FDA Adverse Event Database is 235 but after one year there were suddenly increased by about 100000
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1answer
38 views
What is the difference between OpenFDA's Drug Label API and DailyMed?
I am interested in downloading and processing structured product label (SPL) data. What is the difference between DailyMed API and OpenFDA's (https://open.fda.gov/apis/drug/label/) API?
Is one more ...
1
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1answer
31 views
Existing record (spl_id) now showing not found
We are storing spl_id in our DB and using it as primary key in the API. But after some time, when we search it via the API, we get the following response:
{
"error": {
"code":...
1
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1answer
48 views
OpenFDA NDC endpoint has multiple RXCUI values for a single product NDC
I'm currently operating under the assumption that any two NDCs with the same RxCUI value are pharmaceutical equivalents. Hopefully that's correct.
When querying the NDC data from OpenFDA, I noticed ...
1
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1answer
24 views
FAERS Quarterly Extracts and openFDA
Does anyone know, on average, how long it takes for openFDA to be updated once the quarterly extracts are released? Is there a way to track this? TIA
1
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1answer
24 views
Alignment between openFDA and PV data
I figured it might be worth a shot to pose this question here. We are analyzing adverse event data from openFDA related to a specific product. As an exercise, we looked at specific events over a 10-...
1
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1answer
32 views
OpenFda data seems to grow lot each quarter
Why the data we get from openfda seems to grow a lot each quarter? The 2020Q2 openfda csv file we create is 2.3GB vs the 2019Q2 data which is 1.3GB. On the other hand, the FAERS data only changed from ...
1
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1answer
30 views
Are weekly CRON jobs possbile for for openFDA, new indications_and_usage inquiries?
How would I track new FDA drug indications or other major changes each month?
Example Dupixent expanded its atopic dermatitis indication from 12 years + to 6 years + in May 2020.
How could I set up a ...
1
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1answer
24 views
Total Product Life Cycle API?
I am unable to find any endpoint(s) to fetch TPLC related details in the OpenFDA website or may be i've overlooked.
Is there is an API or other ways to retrieve TPLC related details, could you pls ...
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1answer
29 views
Device Endpoint - Brand Name Mismatch
When we Query Maude Website for Report Number "2024168-2020-03898", brand name is displayed as “ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM”.
However when we use the device end point and ...
1
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1answer
30 views
openFDA API query including “\”
I came across a question. Some of the generic_name contains backward slash sign, for example, CYCLOPHOSPHAMIDE\PREDNISONE\VINCRISTINE. How to construct the API query that can include backward slash ...
1
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1answer
31 views
Device API not returning recent data
Looks like the device end point for adverse events is not returning latest data or I'm missing something.
As on today (Sept 16th) when I trigger the below endpoint:
https://api.fda.gov/device/event....
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0answers
14 views
Crosswalk / Equivalence Mapping from HCPCS (Devices) to FDA Product Code
Is there any available mapping between the HCPCS-II codes associated with medical devices and the 3-letter FDA "Product Code"?
So to be excruciatingly obvious...
The FDA Product Code for ...
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1answer
38 views
openFDA API seems to be missing NDCs
I have some NDCs that I want to search for on the openFDA API:
33992-8010-1
50058-100-08
...etc.
So this is what I've tried so far (all with base url api.fda.gov):
drug/ndc.json?search=product_ndc:&...
1
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1answer
23 views
openFDA decision_code field in PMA device API endpoint
I downloaded the PMA devices dataset from here
https://download.open.fda.gov/device/pma/device-pma-0001-of-0001.json.zip
However, It seems like the denied filings were not included since the ...
1
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1answer
22 views
Need help for Constructing Query String - device/event.json endpoint
I'm trying to get all the filters working for Maude DB via the device/event.json endpoint.
URL
The Filter in the website Brand Name matches to device.brand_name in the API.
Similarly, Need help to ...
1
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1answer
12 views
Missing pma_number in classification endpoint Aug2020 release
I downloaded the device classification dataset from here
Despite being listed in the searchable fields in the documentation, the openFDA field "pma_number" appears to be missing (at least in ...
1
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1answer
30 views
How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED?
How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED? We have limited info on each device such as the model of implanted device and serial number. ...
2
votes
1answer
24 views
openfda: query to obtain links to 510(k) summaries
Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i.e. devices) with summaries. But in the download, the api just produces the ...
1
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1answer
22 views
API returns code not found
For a number of codes found in the National Drug Code directory the API returns code not found.
https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
I have reviewed the API documentation and ...
1
vote
1answer
18 views
How to know ATC Class 1-5 of a drug name in OpenFDA data
I am trying to use OpenFDA open-source data so that I can know ATC Class 1-5 of a drug name and the disease it can be used to treat for?
1
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1answer
29 views
Missing whitespace in label text values?
As context for this question, look at the response for NDA211172 (inotersen) from the label.json endpoint: https://api.fda.gov/drug/label.json?search=openfda.application_number.exact:NDA211172
I have ...
2
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1answer
28 views
OpenFDA Covid19 Serology Tests DB Created_On/Updated_On Fields?
We are looking to monitor data that is added/changed within the DB on a daily basis. When looking at the results returned from the OpenFDA Covid19 Serology Tests API, it appears that in the metadata ...
1
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1answer
23 views
OpenFDA Covid19 Serology Tests missing manufacturer?
-- Missing manfuacturer?:
The manufacturer Beckman Coulter, Inc. is not available in the data as can be seen here
https://api.fda.gov/device/covid19serology.json?count=manufacturer.exact
but it is ...
1
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2answers
64 views
What is the best free database to use to get prescription and otc drugs marketed in the U.S. and approved by FDA?
I'm working on a project to build a drug database that provides drug lookup and information (indications/use, side effects, interactions, etc.) and also provides pricing by pharmacy networks. So, ...
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0answers
24 views
Get product recall information from Open FDA based on the DI or UDI of a product in GUDID
Can UDI or DI codes on product packaging of Medical Devices be used to check for a recall status? Search results from GUDID for product information data, and Open FDA for Recall data, do show some ...
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1answer
46 views
Does OpenFDA have duplicate reports?
In an answer of this specific question on stack exchange:
What does some reports have the same safetyreportid?
It is stated that openfda has duplicates:
'Duplicate and incomplete reports are in the ...
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1answer
43 views
What does the searchable field safetyreportid mean in openFDA drug adverse event api
In the openFDA website(https://open.fda.gov/apis/drug/event/searchable-fields), it said safetyreportid is "The 8-digit Safety Report ID number, also known as the case report number or case ID. ...
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1answer
26 views
How can I import your database downloads into Elasticsearch?
I spent several hours unsuccessfully trying to import the drug json files that you have available in the downloads section into the latest release of elasticseach (7.8.0). The download files don't ...
1
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1answer
50 views
What does some reports have the same safetyreportid?
I thought that safetyreportid is the unique identity of a report, but I found that some safetyreportid like "5390497-5" has two or three reports in openFDA when I search by API:
https://api....
0
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1answer
29 views
OpenFDA Medical Device 510(k) other information than summary/statement
Is it possible to identify all 510k records of medical devices were a FDA review or clinical trials is available (e.g. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151502) ...
1
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1answer
23 views
Search the summary PDF 510k medical device of openfda
Is it possible to search specific terms within the summary or statement PDF of the 510k records of medical devices using either the API, the dataset or an online database?
I found a similar question (...
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1answer
32 views
Incorrect Product Code in OpenFDA Recalls Database
I noticed that when I look at product recall "Z-1973-2012" in the OpenFDA Recalls database, it returns with a result containing Product Code "CGA".
However the same recall number on FDA's Recall ...
1
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1answer
23 views
Is “event_key” meant to be empty?
If you review the raw data documentation and any accompanying research papers, you will be informed that "event_key" is meant to be an important field.
Master Event Data: A distinct master event data ...
1
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1answer
41 views
Is it possible to search using multiple criteria
Is it possible to search OpenFDA using multiple search fields. Separately both terms work but I can't figure out how to search using both at the same time.
This is what I tried that does not work to ...
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1answer
74 views
open FDA Recalls API endpoint does not have same information as accessdata.fda.gov
I am trying to pull data from openFDA for a 2007 medical device recall. On the FDA website I can see all the details - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64517 such as ...
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0answers
35 views
Do we need to consider a duplicate report in openFDA adverse event database? (like patient and doctor both submitted reports)
I am trying to search data with the drug name Hydroxychloroquine from the URL here from OpenFDA api
https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct:%22hydroxychloroquine%22+...
0
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1answer
45 views
How Reliable are the Data
I am trying to search data with the drug name Hydroxychloroquine from the URL here from OpenFDA API
https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct:%22chloroquine%22+AND+...
1
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1answer
38 views
NDC - SETID Mapping
I am interested in connecting the NDC data (brand_name, labeler etc.) to the FDA Label data (SET_ID). However, I'm struggling to find a dataset that would contain the mapping between the NDC code and ...
2
votes
1answer
56 views
What Determines if a Drug appears on OpenFDA or Not?
I'm attempting to use OpenFDA to query a drug's package NDC and return information like manufacturer, brand name, and route.
I have the following query working, but noticed (during testing) I get no ...
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1answer
67 views
MAUDE data frontend vs API
I am trying to use the openfda API to get a view of the data in the front end.
This is an example of a front end search:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?...
