Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985

Regulatory NewsRegulatory News | 21 February 2020 |  By 

To provide researchers with more accurate and accessible data about historic drug approvals, the US Food and Drug Administration (FDA) on Friday released a dataset containing information about all new drugs and biologics approved by the Center for Drug Evaluation and Research (CDER) dating back to 1985.
“FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug,” FDA writes, adding that the compilation should accurately reflect “the state of each application at the time of initial regulatory approval.”
The compilation itself is a downloadable .CSV file containing information on more than 1,000 new molecular entities (NMEs) and new biologics approved from 1 January 1985 through 31 December 2019.
For each product, the spreadsheet provides the proprietary name, active ingredient/moiety, applicant, application type, application number, dosage form, route of administration, receipt and approval dates, approved indications and uses, designations and whether a priority review voucher was issued or redeemed for the application.
Because the compilation is intended to provide information about products at the time of their original approval, some information, such as supplemental indications granted after the initial approval, are not included.
The agency says it will update the compilation periodically with new approval data, and asks that feedback and corrections be send to CDER.NMENewBiologicApprovals@fda.hhs.gov.
FDA has also published a “data dictionary” to accompany the compilation that provides a definition of each field included in the spreadsheet.


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