Questions tagged [openfda]

Questions and answers surrounding the U.S. Food and Drug Administration's OpenFDA program.

Filter by
Sorted by
Tagged with
0
votes
0answers
5 views

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): ...
0
votes
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?
0
votes
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. ...
1
vote
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
vote
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
vote
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
vote
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 ...
0
votes
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 ...
0
votes
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
vote
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
1
vote
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
vote
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
vote
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
vote
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
vote
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
vote
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
vote
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
vote
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 ...
1
vote
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
vote
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
vote
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....
1
vote
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 ...
0
votes
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
vote
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
vote
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
vote
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
vote
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
vote
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
vote
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
votes
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
vote
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
vote
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, ...
1
vote
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 ...
1
vote
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 ...
1
vote
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. ...
1
vote
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
vote
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
votes
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
vote
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 (...
1
vote
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
vote
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
vote
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 ...
1
vote
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 ...
1
vote
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
votes
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
vote
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 ...
1
vote
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?...

1
2 3 4 5 6