Details
This protocol will guide a one-time assessment of the association between parenteral iron products and anaphylactoid/anaphylactic reactions. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.
This protocol was posted for public comment from September 4, 2013 through September 18, 2013. The public comment period is now closed. A revised version was approved for implementation by FDA on January 8, 2014. A log of changes is included in the revised protocol (v2.0).
Additional Information
Contributors
Kathleen Walsh MD, MSc; Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
Cunlin Wang MD, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Susan Andrade ScD; Joann Wagner MSW; Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, MA
Maryam Asgari MD, MPH; Kaiser Permanente Northern California, Oakland, CA
Irene Fung MD; Peter Reese MD, MSCE; University of Pennsylvania School of Medicine, Philadelphia, PA
Monika Houstoun PharmD, MPH; Robert Kane MD; Mark Levenson PhD; Marsha Reichman PhD; Qin Ryan MD, PhD; Diqiong Xie PhD, MS; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Lingling Li PhD; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Gayathri Sridhar PhD, MBBS, MPH; HealthCore Inc., Wilmington, DE