Monica A Munoz,

Severe gastrointestinal adverse reactions including perforation, ulceration, hemorrhage, and obstruction: A fumaric acid ester class new safety risk.

Triple challenges-small sample size in both exposure and control groups to scan rare maternal outcomes in a signal identification approach: a simulation study.

Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System.

Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs.

Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women.

Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants-Associated Cutaneous Small Vessel Vasculitis.

Discontinuation of Direct Oral Anticoagulants in Response to Attorney Advertisements: Data From the FDA Adverse Event Reporting System.

Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.