Annual Reporting

 Submit an annual report to FDA  Search the annual reporting database  Download the database file Annual Licensure Reporting RequirementsWholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure and other...

Impact Story

CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions.As they make decisions about which drug products should be prescribed to their patients, physicians must process a great deal of relevant information in a...

Completed PDUFA VI Deliverables

Assessment in Support of Sentinel SystemPublic Report FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion and integration on FDA’s use of Sentinel for regulatory purposes. Enhancement and modernization...