Getting newly approved drugs from any of the Drug API Endpoints

Question

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 their site. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020

I am not interested as much in shortages, recalls, etc.

My questions is (a) which openFDA endpoint do I need (Drugs@FDA? Product labeling?)? and (b) will this endpoint have the fields I need / is there a way to get the fields I need?

I am interested in getting

• generic name for a given drug
• tissue type or oncotree type the drug applies to
• some sort of open text field regarding the "-INDICATIONS AND USAGE-" section of the prescribing info that I can use to mine relevant genes and/or conditions relating to the drug.

I feel like this should be possible and this information should be available but I am a bit confused by openFDA as a whole right now.

Additionally there seems to be many RSS feeds on the FDA site but there isn't one that seems to correlate to the FDA Drugs emails I subscribe to (Drugs / Oncology Drugs). If there was such a feed, I could use the drug names from that to query Drugs@FDA.

Answer 1

openFDA does not have an easy way to provide 100% accurate results to your query, but you could search the Drug Label endpoint and get "new" labels by filtering on effective_time and also looking in indications_and_usage for indications of a cancer drug, for example:

https://api.fda.gov/drug/label.json?search=indications_and_usage:%22cancer%22+AND+effective_time:[20210101+TO+20211231]+AND+openfda.product_type.exact:%22HUMAN%20PRESCRIPTION%20DRUG%22&sort=effective_time:desc&limit=100

Then you would need to cross-check the results with the Drugs@FDA endpoint to make sure the drugs in fact have had a recent FDA approval.