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2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). Hicks KA, et al. Among authors: joffe hv. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048. J Am Coll Cardiol. 2018. PMID: 29495982 Free article. Review.
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). Hicks KA, et al. Among authors: joffe hv. Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502. Circulation. 2018. PMID: 29483172 Review.
Rosiglitazone and the FDA.
Joffe HV, Parks MH, Meyer RJ, Jenkins JK, Temple R. Joffe HV, et al. N Engl J Med. 2007 Oct 25;357(17):1775-6; author reply 1777. doi: 10.1056/NEJMc076347. Epub 2007 Aug 29. N Engl J Med. 2007. PMID: 17761586 No abstract available.
Regulatory news: Nulibry (fosdenopterin) approved to reduce the risk of mortality in patients with molybdenum cofactor deficiency type A: FDA approval summary.
Farrell S, Karp J, Hager R, Wang Y, Adeniyi O, Wang J, Li L, Ma L, Peretz J, Summan M, Kong N, White M, Pacanowski M, Price D, Filie J, Donohue K, Joffe H. Farrell S, et al. J Inherit Metab Dis. 2021 Sep;44(5):1085-1087. doi: 10.1002/jimd.12421. Epub 2021 Aug 8. J Inherit Metab Dis. 2021. PMID: 34337775 Review. No abstract available.
FDA Regulation of Prescription Drugs.
Gassman AL, Nguyen CP, Joffe HV. Gassman AL, et al. Among authors: joffe hv. N Engl J Med. 2017 Feb 16;376(7):674-682. doi: 10.1056/NEJMra1602972. N Engl J Med. 2017. PMID: 28199811 Review. No abstract available.
Testosterone and "Age-Related Hypogonadism"--FDA Concerns.
Nguyen CP, Hirsch MS, Moeny D, Kaul S, Mohamoud M, Joffe HV. Nguyen CP, et al. Among authors: joffe hv. N Engl J Med. 2015 Aug 20;373(8):689-91. doi: 10.1056/NEJMp1506632. N Engl J Med. 2015. PMID: 26287846 Free PMC article. No abstract available.
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