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The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS). The FAERS data in the DTD Descriptor contains a field that identifies whether the product at issue is a combination product. https://www.fda.gov/combination-products/guidance-regulatory-information/reporting-elements-combination-products. It should be "combinationproductreport". But I cannot find that field in the downloaded dataset. Can anyone tell me where it is? I searched in the searchable fields and did not find it. Is there any workaround if it is not there?

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  • Thanks for the information.
    – Brad
    Commented Jan 5 at 18:52

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Unfortunately, FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files, which openFDA uses as a source for its Drug AE API, do not contain any information about safety reports for CDER and CBER-regulated combination products, and the openFDA team is unaware of a workaround. You would need to contact the FDA directly to see if this is going to change in the future. Sorry about the inconvenience.

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