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Review

‘Approved for use in uveitis’: drug approval for an orphan disease

, MS MPH & , MD FACS FACR

Bibliography

  • How Drugs are Developed and Approved. Drugs. [Online] US. Food and Drug Administration, 2014. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm [Cited 13 April 2015]
  • Food and Drug Administration. Part 314: Applications for FDA Approval to Market a New Drug; Subpart D: FDA Action on Applications and Abbreviated Applications. Department of Health and Human Services. 2014. Code of Federal Regulations, Title 21: Food and Drugs. Chapter I: Food and Drug Administration
  • Drug Label Database. FDALabel - Full-Text Search of Drug Label Database. [Online] US. Food and Drug Administration, 2014. Available from: https://rm2.scinet.fda.gov/druglabel/#lblsums-4 [Cited 13 April 2015]
  • Foster CS, Vitale AT. Diagnosis and Treatment of Uveitis. 2nd Edition. Jaypee Brothers; New Dehli: 2013
  • Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol 2000;130(4):492-513
  • US. National Institutes of Health. ClinicalTrials.gov. [Online] Available from: http://www.clinicaltrials.gov/ct2/results?term=adalimumab&Search=Search [Cited 13 April 2015]
  • Schneider R. Humira gains FDA orphan drug designation. North Chicago: Ophthalmology Times 2014
  • Barreto A. XOMA Receives Orphan Drug Designation From U.S. Food & Drug Administration for Gevokizumab. Berkeley: XOMA Corporation 2012
  • pSivida Corp. Products/Pipeline. [Online] Available from: http://www.psivida.com/pipeline.html [Cited 13 April 2015]
  • Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology 1985;92(4):467-71
  • Jabs DA. Standardization of Uveitis Nomenclature for Reporting Clinical Data. Results of the First International Workshop. Am J Ophthalmol 2005;140(3):509-16
  • Madow B, Galor A, Feuer WJ, et al. Validation of a photographic vitreous haze grading technique for clinical trials in uveitis. Am J Ophthalmol 2011;152(2):170-6
  • Kempen JH, Ganesh SK, Sangwan VS, Rathinam SR. Interobserver agreement in grading activity and site of inflammation in the eyes of patients with uveitis. Am J Ophthalmol 2008;146(6):813-18
  • Davis JH, Madow B, Cornett JI, et al. Scale for photographic grading vitreous haze. Am J Ophthalmol 2010;150(5):637-41
  • Denniston AK, Dick AD. Systemic therapies for imflammatory eye disease: Past, Present, and Future. BMC Ophthalmol 2013;13:18
  • Hornbeak DM, Payal A, Pistilli M, et al. Interobserver agreement in clinical grading of vitreous haze using alternative grading scales. Ophthalmology 2014;121(8):1643-8
  • Keane PA, Karampelas M, Sim DA, et al. Objective measurement of vitreous inflammation using optical coherence tomography. Ophthamology 2014;121(9):1706-14
  • Konstantopoulou K, Del’Omo R, Morley AM, et al. A comparative study between clinical grading of anterior chamber flare and flare reading using the Kowa laser flare meter. Int Ophthalmol 2012. [Epub ahead of print]

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