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Questions tagged [openfda]

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

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1 vote
2 answers
35 views

Some 510k records with 'statement' value stored in the summary searchable field from openFDA do not have summary information from FDA database

I see there is a searchable field called 'summary_or_statement' from openFDA API to indicate the summary or statement result. However, some records with "statement' value for the ...
0 votes
1 answer
82 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 ...
0 votes
1 answer
32 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 ...
1 vote
1 answer
47 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 ...
0 votes
1 answer
59 views

Using the openfda API, is there a way to download the 510(k) summary documents using the API? Or simple get the links to those summaries?

I can use the API to determine if a "statement_or_summary" exists. Is there a way to download the 510(k) summary documents, or get links to those documents? I am fine ignoring the documents ...
0 votes
1 answer
26 views

openfda results in spl_patient_package_insert_table not rendering HTML correctly

I'm accessing the spl_patient_package_insert_table data in the https://api.fda.gov/drug/label.json endpoint. The HTML returned in this field is not rendering correctly in a browser. Does this ...
0 votes
1 answer
10 views

Missing mdr_text data in openFDA Device Adverse Events [/device/event] API results

We have noticed that since the openFDA /device/event update on 2024-06-04 the the API results return empty mdr_text fields for all records (e.g., "mdr_text": []). We have not confirmed if ...
0 votes
1 answer
21 views

Deviation between OpenFDA API and Maude Pt. 2

We have encountered several situations where there is a deviation between the results generated when performing a search via Maude and the OpenFDA API. Below are two examples that we wish to get some ...
1 vote
1 answer
108 views

The openFDA API supports searching by range in date not working?

I would like to create an URL, that shows me all reports from the MAUDE database from December with the product key 'MQB'. I created the this URL as an attempt: https://api.fda.gov/device/recall.json?...
0 votes
1 answer
44 views

The difference between exact with suffix and without suffix

Can you explain the difference between searching on OpenFDA with the .exact suffix, and without the suffix? I'm a little confused
0 votes
1 answer
46 views

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: ...
1 vote
1 answer
74 views

openFDA - Open APIs to access Import Alerts, Import Refusals, Warning Letters & Inspection details

Does openFDA have APIs to access Import Alerts, Import Refusals, Warning Letters & Inspection details for a Supplier?
1 vote
1 answer
68 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 ...
0 votes
1 answer
24 views

How do you use the sorting function in OpenFDA for registration listing?

Can you sort "sort=receivedate:desc&limit=10" under the registration listing for product.created_date?
1 vote
1 answer
65 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
2 answers
104 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 ...
0 votes
1 answer
38 views

Cannot search by NDC string

I would like to search for a drug by the NDC like this https://api.fda.gov/drug/ndc.json?search=product_ndc:"54868-4517"&limit=100 but I get a { error: { code: "NOT_FOUND", ...
0 votes
1 answer
19 views

Deviation between results from OpenFDA API and Maude - Adverse events medical devices PRD Code

When running this query via the OpenFDA API: https://api.fda.gov/device/event.json?search=(device.device_report_product_code:KQM+AND+date_report:%5B20230101+TO+20230430%5D)&limit=20 From the ...
1 vote
2 answers
58 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 ...
1 vote
1 answer
102 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
1 answer
84 views

Device Product Code API call

I'm trying to return medical device "product_code" data, but the following two URLs do not work. For example, I'm trying to get data on the product code, "DXN" as listed here: https://www.accessdata....
1 vote
2 answers
76 views

How to download a subset of the reports based on a specific indication of query term?

I understand that for performance purposes in my case it will be better to download the data rather than accessing it through the public API. On a practical note I am only interested in a subset of ...
1 vote
1 answer
278 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
1 vote
1 answer
67 views

Retrieve the Supplier details using FEI number?

a. Can we retrieve the Supplier details using FEI number, in any of the APIs? b. Are there any datasets or APIs available to query information under Cosmetics? c. Are there any open APIs to fetch ...
1 vote
1 answer
75 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....
1 vote
1 answer
161 views

Can we get the dosage list for a drug

How can we get the dosage list for a particular drug. we have the key "dosage_forms_and_strength" but it gives a single string not in a list format. I need to bind a dropdown for dosage information ...
1 vote
1 answer
124 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 ...
0 votes
1 answer
23 views

PMA data does not match FDA database

I am seeking to understand the source of data discrepancies between the openFDA API and the FDA database. For example I am using the following query to find all records that match a PMA submission ...
0 votes
3 answers
113 views

Missing certain data in API

We are using the below API to fetch data based on dates: https://api.fda.gov/device/event.json?api_key=MyAPIKey&search=date_received:[20230702+TO+20230704]AND+device.device_report_product_code....
0 votes
1 answer
28 views

302 Moved Temporarily

We are trying to fetch the data using below URL: http://www.accessdata.fda.gov/MAUDE/ftparea/DEVICEAdd.zip but it continuously gives below error as: Reusing existing connection to www.accessdata.fda....
0 votes
1 answer
158 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 ...
0 votes
1 answer
33 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 ...
0 votes
1 answer
83 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 ...
3 votes
1 answer
90 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
1 answer
71 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
1 answer
52 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. ...
0 votes
1 answer
34 views

Is there a way to extract NCT ID, approval order, post-approval study links from PMA database with openFDA api?

I am wondering if it is possible to add more searchable fields to the openFDA api PMA database such as NCT ID, approval order link and post-approval study link? Or adding something to determine which ...
0 votes
1 answer
46 views

Device recalls - difference between date entry was created in openFDA database and date manufacturer informed about recall

I am using the recalls database to always be aware of the recalls for some specific vendors and products. This is the call I am doing: https://api.fda.gov/device/recall.json?search=recalling_firm:(&...
0 votes
1 answer
32 views

Patient age is not displayed correctly

Patient Age is displayed as below: Patient Age 19710 DA using the below URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=16232230&pc=CCK&device_sequence_no=...
0 votes
1 answer
31 views

Why does device.device_report_product_code require = rather than :?

To successfully search the device/event endpoint for device.device_report_product_code, you must search using = instead of : like this: https://api.fda.gov/device/event.json?search=device....
0 votes
1 answer
71 views

mdr text is missing for many report numbers

I am using the below mentioned adverse event device open API url but it is not giving MDR text for many report numbers like 2112667-2023-03226, 2112667-2023-03227, 2112667-2023-03228 etc though the ...
0 votes
1 answer
26 views

FDA API not working since last month

The FDA API is not able to extract data for the month of May and June. The API used in collecting the data for May is given below: 'https://api.fda.gov/device/event.json?search=date_received:[20230501+...
1 vote
1 answer
100 views

How to format openFDA API results?

I am able to retrieve the results for a drug from the openFDA via PHP; however the results are just strings of text without any indicators for formatting such as html tags or splitting them up into ...
1 vote
1 answer
158 views

Why does the data on website not match what is returned from the api

I am trying to get data similar to what is shown on https://www.fda.gov/Safety/Recalls/default.htm using the api, but I am seeing a lot of discrepancies. For example when I use the following api ...
0 votes
2 answers
79 views

Discrepancy between MAUDE and API Search Results

Here an update to my previous post with additional details and an answer to the initial response: Unfortunately the measures listed above did not remedy the problem we are facing. Maybe it would help ...
0 votes
1 answer
20 views

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?
1 vote
1 answer
91 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 ...
2 votes
1 answer
200 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 ...
1 vote
1 answer
102 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
1 answer
50 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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