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The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).
Desai RJ, Marsolo K, Smith J, Carrell D, Penfold R, Pillai HS, Lii J, Ngan K, Winter R, Adgent M, Ramaprasan A, Driscoll MR, Scarnecchia D, Kiernan D, Draper C, Lyons JG, Khurshid A, Maro JC, Zimmerman R, Brown J, Bright P, Hernández-Muñoz JJ, Matheny ME, Schneeweiss S. Desai RJ, et al. Among authors: lii j. Pharmacoepidemiol Drug Saf. 2024 Oct;33(10):e70028. doi: 10.1002/pds.70028. Pharmacoepidemiol Drug Saf. 2024. PMID: 39385712
Removing the FDA's Boxed Hepatotoxicity Warning and Liver Function Testing Requirement for Ambrisentan.
Feldman WB, Mahesri M, Sarpatwari A, Huybrechts KF, Zhu Y, Hwang CS, Lii J, Lee SB, Kattinakere Sreedhara S, Toyserkani GA, Zhou EH, Zendel L, LaCivita C, Manzo C, Dal Pan GJ, Kesselheim AS, Bykov K. Feldman WB, et al. Among authors: lii j. JAMA Netw Open. 2024 Jul 1;7(7):e2419873. doi: 10.1001/jamanetworkopen.2024.19873. JAMA Netw Open. 2024. PMID: 39023895 Free PMC article.
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000-2020.
Mahesri M, Sarpatwari A, Huybrechts KF, Lii J, Lee SB, Toyserkani GA, LaCivita C, Zhou EH, Dal Pan GJ, Kesselheim AS, Bykov K. Mahesri M, et al. Among authors: lii j. Drug Saf. 2024 Sep;47(9):909-919. doi: 10.1007/s40264-024-01443-3. Epub 2024 May 16. Drug Saf. 2024. PMID: 38755509
104 results