Venclexta Reviewers
Executive Summary
FDA staff who participated in the review of AbbVie/Roche's second-line treatment for chronic lymphocytic leukemia with 17p deletion.
Venclexta FDA Reviewers |
|
Medical |
Lori Ehrlich |
Statistics |
Qing Xu, Yuan-Li Shen |
Pharmacology/Toxicology |
Ramadevi Gudi, Emily Place, Christopher Sheth, John Leighton |
Quality |
Rajiv Agarwal, Monica Cooper, Gerlie Gieser, Ruth Moore, Tracey Rogers |
Clinical Pharmacology and Biopharmaceutics |
Guoxiang Shen, Lian Ma, Justin Earp, Sarah Dorff, Bahru Habtemariam, Nitin Mehrotra, Rosane Charlab Orbach, Nam Atiqur Rahman |
Risk Assessment and Mitigation |
Mona Patel, Naomi Redd, Cynthia LaCivita |
Cross Discipline Team Leader |
Virginia Kwitkowski |
Regulatory Health Project Manager |
Beatrice Kallungal |