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Page 1
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.
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.
FDA Approval of Flibanserin--Treating Hypoactive Sexual Desire Disorder.
Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, Lehrfeld K, Lee L, Kim MJ, Slagle AF, Beitz J. Joffe HV, et al. N Engl J Med. 2016 Jan 14;374(2):101-4. doi: 10.1056/NEJMp1513686. Epub 2015 Dec 9. N Engl J Med. 2016. PMID: 26649985 Free article. No abstract available.
FDA approval of doxylamine-pyridoxine therapy for use in pregnancy.
Slaughter SR, Hearns-Stokes R, van der Vlugt T, Joffe HV. Slaughter SR, et al. Among authors: joffe hv. N Engl J Med. 2014 Mar 20;370(12):1081-3. doi: 10.1056/NEJMp1316042. N Engl J Med. 2014. PMID: 24645939 Free article. No abstract available.
FDA approval of paroxetine for menopausal hot flushes.
Orleans RJ, Li L, Kim MJ, Guo J, Sobhan M, Soule L, Joffe HV. Orleans RJ, et al. Among authors: joffe hv. N Engl J Med. 2014 May 8;370(19):1777-9. doi: 10.1056/NEJMp1402080. N Engl J Med. 2014. PMID: 24806158 Free article. No abstract available.
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.
26 results