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research:angioedema [2016/12/13 17:24] jduke |
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**Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | **Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | ||
- | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, Martijn Schuemie, George Hripcsak, Christian Reich, Yuri Khoma, Marie-Sophie Schwalm, ...... more pending | + | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, Martijn Schuemie. |
**Coordinating Institution(s):** Regenstrief Institute / Georgia Tech | **Coordinating Institution(s):** Regenstrief Institute / Georgia Tech |