Reviews of clinical study reports and related documents for approved drugs, written by staff from the US Food and Drug Administration (FDA). Drug Approval Packages can be found of the Drugs@FDA website. Drug Approval Packages generally include the approval letter, summary review, medical review, chemistry review, pharmacology review, statistical review, clinical pharmacology biopharmaceutics review and microbiology review. Drug Approval Packages may also include the printed labeling, officer/employee list, office director memo, proprietary name review and administrative documents and correspondence and other reviews. FDA makes similar documents available for biologics under the Center for Biologics Evaluation and Research (CBER) website. Also see: European Public Assessment Report, Australian Public Assessment Report.
Example: Sivextro (Tedizolid Phosphate) (source)
« Back to Glossary Index