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  1. Drug Safety and Availability

FDA launches new resource to provide easily accessible, more accurate historical drug approval data

[2/21/2020] FDA is launching a new resource to assist external and agency researchers collecting historical information about FDA’s drug approvals. The Compilation of Center for Drug Evaluation and Research (CDER) New Molecular Entity (NME) Drug and New Biologic Approvals is a .CSV file available on the agency’s website that will provide researchers with curated data regarding drug products approved by CDER since 1985.

FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug. Although FDA continues to provide updated information on its drug approvals through several other publicly accessible sources, this new resource will consolidate information for each NME approval. The data published in this compilation is derived from FDA internal databases and document records, and—to the best of our knowledge—reflects the state of each application at the time of initial regulatory approval.

CDER will manage the compilation and will update it periodically with the latest drug approval data. This first edition will contain data on drugs approved by FDA between January 1, 1985, and December 31, 2019. To ensure the compilation is fulfilling its intended purpose of being an accessible and useful data source, FDA encourages the public to submit any feedback, data corrections, and questions to CDER.NMENewBiologicApprovals@fda.hhs.gov.

By launching this compilation, FDA intends to meet researchers’ requests for more accessible information by capturing drug-approval data reported across FDA’s official sources within one resource. The agency is also continuing to seek out additional opportunities to provide more easily-accessible and accurate drug-approval data in the future.


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