21 February 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.