Questions tagged [openfda]

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

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1answer
9 views

The difference between exact with suffix and without suffix

Can you help me explain the difference between exact with suffix and without suffix? I'm a little confused
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1answer
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how to modify time range in interactive chat?

Deadlines are always up to date in interactive chat ,for example:i want to query time range between 2015/01/01-2020/01/01.how to modify?
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FDA Api Issue with Brackets

When I'm making what seems like a working query: https://api.fda.gov/food/enforcement.json?api_key=123&search=report_date:[2021111+TO+20211112] I get an error: [token_mgr_error] token_mgr_error: ...
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https://openfda.shinyapps.io/RR_D/ can not work

https://openfda.shinyapps.io/RR_D/ can not work ,error:Peer certificate cannot be authenticated with given CA certificates How do I make this site work?
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1answer
18 views

Why are the results of two search statements inconsistent?

https://api.fda.gov/drug/event.json?search=(receivedate:[20040108+TO+20210401])+AND+patient.drug.medicinalproduct:%22IBUPROFEN%22&count=patient.reaction.reactionmeddrapt.exact Using the above ...
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1answer
46 views

How can I list FDA approved drugs in a year?

I am trying to list all of the approved drugs in a particular year, (e.g. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-...
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1answer
12 views

How to obtain ROR and PRR of an adverse drug event using openFDA

I am writing a paper on adverse reaction mining, and I need to calculate ROR and PRR values of all adverse reactions of a drug. May I ask how to use openFDA to build query statements?
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1answer
15 views

Filtering pma dataset for only new PMA decisions (that is, no supplmements)

All - admittedly, a beginner question. I'm looking at the most recent pma json dataset from OpenFDA to understand trends in new applications over time and by geographic location. My first look at ...
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1answer
53 views

New Indications via OpenFDA API

Is it possible to access new indication submissions or approvals via the OpenFDA API? I can see the information that I am looking for via the the Drugs@FDA website. For example, the page for Jakafi ...
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8 views

list of breakthrough drugs

I'm looking for a list of drugs which have been granted Breakthrough Therapy designation by the FDA. I can easily find drugs that have been approved which have this status (Approved Breakthrough Drugs)...
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1answer
30 views

Uniquely Identify Items in OpenFDA (MAUDE)

Im downloading and processing the complete data of OpenFDA as described in: https://open.fda.gov/apis/downloads/ https://api.fda.gov/download.json But i could not find a way to uniquely identify the ...
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1answer
16 views

Is there an identifier that might indicate 505(b)(1) vs 505(b)(2) filing?

I'm skimming through the Drugs@FDA dataset, and I'm wondering if any of the identifiers would tell me which pathway the application went through. Of the options, SubmissionClassCodeID seems most ...
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14 views

Drug side effect dataset

Does anyone knows where I could find a dataset which lists the known side effects for every drug. Initially, I've found SIDER (http://sideeffects.embl.de/) and OFFSIDER (http://tatonettilab.org/...
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1answer
11 views

No inactive_ingredient field when query for drug substance in Drug Label API

I am looking for the inactive ingredients for a dozen of different drugs. However when querying in the Label API, most results return without an "inactive_ingredient" field. The field only ...
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1answer
36 views

OpenFDA - Parsing Indications and Dosage Variables

I have a question about parsing two specific variables from the Product Labeling Endpoint on OpenFDA: indications_and_usage dosage_and_administration Ideally I would like to: Extract each ...
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1answer
15 views

Combined search query of openfda.generic_name and inactive ingredients only provides info for OTC products?

I think the title explains the question. Im trying to run a query that pull specified legend drug name and specified inactive ingredient. The results only seem to have an inactive ingredient ...
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1answer
64 views

Extracting data from OpenFDA using python to save it locally

I have been looking to extract all data from FDA so I can use it all. I created this code below that works but seems it is too much data it fails. This way it just gives me 25000 records. url = '...
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19 views

Well-formatted drug listings sections

I've written an app to search and display ophthalmic medications. When uses select a medication I query the open.fda.gov APIs to get the specific listings for that medication. example API call result ...
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1answer
25 views

Q1 2021 Drug Event Endpoint Update

It looks like the Q1 2021 FAERS release was posted on 10-May-2021. Does anyone know when openFDA will refresh its Drug Event endpoint to include the new data? I know this typically occurs once a week, ...
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1answer
67 views

Can I use openFDA API for Drugs side effects?

Is there any way to get Drugs side effect for specific drug name like Paxil from openFDA API. I read the documentation but don't really understand
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1answer
55 views

(Drug API with NDC) Drug name with specified strength & NDC Error

Our website is a platform for patients to consult with physicians and specialists on-demand. The doctors will be able to search for the drug name though the database (NDCID drug database integrated in ...
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1answer
43 views

How to know which drug product is a reference listed drug (RLD)?

I trying to figure out how to know which drug product is a reference listed drug (RLD). Let's take for an example following spl_set_id: https://api.fda.gov/drug/drugsfda.json?search=products....
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1answer
31 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): ...
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1answer
30 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
70 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
20 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%...
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1answer
51 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, ...
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1answer
62 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 ...
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1answer
20 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
27 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
19 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 ...
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1answer
19 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
71 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 ...
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1answer
36 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":...
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1answer
55 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 ...
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1answer
34 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
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1answer
29 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-...
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1answer
37 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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1answer
37 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
42 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
36 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
37 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
35 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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1answer
26 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
60 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
50 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
26 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 ...
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1answer
15 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 ...
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1answer
38 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
37 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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