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

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16 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 ...
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8 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 ...
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1answer
18 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
26 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 ...
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1answer
21 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 ...
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1answer
20 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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9 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
20 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:&...
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1answer
8 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 ...
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1answer
14 views

Need help for Constructing Query String - device/event.json endpoint

I'm trying to get all the filters working for Maude DB via device/event.json endpoint. URL : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm The Filter in the website Brand Name ...
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1answer
10 views

Missing pma_number in classification endpoint Aug2020 release

I downloaded the device classification dataset from here: https://open.fda.gov/apis/device/classification/download/ Despite being listed in the searchable fields in the documentation, the openFDA ...
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1answer
25 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. ...
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1answer
12 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 ...
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1answer
14 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 ...
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1answer
13 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?
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1answer
26 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 ...
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1answer
23 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 ...
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1answer
20 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 ...
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2answers
37 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 provide pricing by pharmacy networks. So, apart ...
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0answers
20 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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0answers
33 views

Does OpenFDA has 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
34 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
17 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 ...
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1answer
39 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....
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1answer
23 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) ...
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1answer
16 views

Search the summary PDF 510k medical device of openfda

Is it posible to search specific terms within the summary or statement PDF of the 510k records of medical devices using either the API, the dataset (https://open.fda.gov/apis/device/510k/download/) or ...
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1answer
29 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 ...
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1answer
17 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 ...
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1answer
28 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
65 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
29 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+...
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1answer
33 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+...
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1answer
24 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
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1answer
53 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 ...
0
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1answer
60 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?...
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1answer
25 views

What characters are allowed in the search parameter of the NDC OpenFDA API request?

I'm having an issue where the NDC API returns errors when special characters are submitted in the search parameter. I working on a product that contains a search box that allows the user to lookup ...
1
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1answer
50 views

Unzipping the openfda data in R

I've downloaded all the url's for the different drug-event pairs, but they all end in .zip. Does anyone know how to automate pulling the .json file out of these zip files without doing it manually for ...
1
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1answer
55 views

Open FDA API - LIKE search condition

I am interested in finding a syntax for the LIKE search condition. The query syntax example is https://api.fda.gov/drug/ndc.json?search=brand_name:aspirin I have to enter the whole word (aspirin) ...
0
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1answer
42 views

Query Open FDA for application_number, ndc, and rxcui

My apologies if this has been asked: I am new to using OpenFDA and am trying to query the database to obtain a list of the ndc and rxcui associated with a particular application numbers appearing in ...
2
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1answer
78 views

OpenFDA API Suspension effective 12/20/2019?

I'm wondering if anybody has any knowledge around the current suspension. None of the APIs have been updated since 12/14/2019, and the API status page currently reads, "Currently, there is a temporary ...
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1answer
21 views

Hazard and NIOSH Code and Information for Prescription Drugs

Is there an API endpoint via OpenFDA or some other source that will give me Hazard and NIOSH codes for a specific drug based on NDC number or some other code? For example, the drug WARFARIN SODIUM- ...
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0answers
10 views

Is there an OpenFDA API That shows if a drug is hazardous to handle?

Is there an API that I can hit to see if a drug is categorized as hazardous to handle. Is there a property such as: IsHazardous or either an OSHA or NIOSH value in one of the APIs?
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1answer
33 views

Retrieving names of drug that include spaces from specific adverse reactions

I am trying to extract the top 100 drugs related to the highest number of adverse reaction of a specific type. For example, I would like to extract the top 100 drugs that have been reported as ...
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2answers
69 views

How to download data more than limit of option “limit” and “skip”

I am using this api https://api.fda.gov/drug/ndc.json. But as per limitation, we can't pass limit more than 100 and value for Skip is 25000. But in the data, if we have more than 100K + record. How ...
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1answer
79 views

Package NDC Query

I am trying to query OpenFDA to get some data on the following product: https://ndclist.com/ndc/52380-0001/package/52380-0001-3 I have tried querying 52380000103, 5238000013, 5238000103 and ...
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0answers
23 views

Looking for an endpoint to retrieve warning letters

You can search for warning letters https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
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1answer
50 views

using barcode value to lookup drug information

I am trying to build a query tool that takes a scanned barcode (NDC) and looks up the drug information in the openFDA. I have a package for Latanoprost Ophthalmic Solution with a package code of ...
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0answers
19 views

Where can I find FDA approval SPL drug data?

I am doing a study on approval label drug data for prescription drugs and want to get a a large dataset of the approval label for a drug. I will be then comparing this with later versions of the drug ...
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0answers
71 views

OpenFDA End Point Updates

With respect to the US Food and Drug Administration's API, I haven't seen the end points updated since 8/12/19. Did something change or is this common? I've noticed the end points refreshed fairly ...
1
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1answer
77 views

Mapping of drug names to generics

Dataset: Obtained from FDA AERS I would like to map the drug names to its generic name. Example: Arthritis Pain, Aspir 81, Aspir-Low, Bayer Childrens Aspirin etc would be mapped to aspirin Is there ...

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