Details
Methods project to develop a planning procedure to optimize the use of the Tree-Based Scan Statistic for newly licensed vaccines and reports related to Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires that postmarket evaluations are performed 18 months after approval of the drug or after it is used by 10,000 individuals, whichever is later.
Additional Information
Contributors
Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Martin Kulldorff, PhD; Alison Kawai, PhD; Meghan Baker, MD; Inna Dashevsky MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Michael Nguyen, MD; John Scott, PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD