메뉴 건너뛰기




Volumn 351, Issue , 2015, Pages

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: Systematic review

Author keywords

[No Author keywords available]

Indexed keywords

AGENTS ACTING ON THE PERIPHERAL NERVOUS AND NEUROMUSCULAR SYSTEMS; ANTIBIOTIC AGENT; ANTINEOPLASTIC AGENT; CARDIOVASCULAR AGENT; GASTROINTESTINAL AGENT; ORPHAN DRUG; PLACEBO; PRESCRIPTION DRUG; PSYCHOTROPIC AGENT;

EID: 84947205197     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h4679     Document Type: Review
Times cited : (38)

References (31)
  • 1
    • 79955553942 scopus 로고    scopus 로고
    • Availability of comparative efficacy data at the time of drug approval in the United States
    • Goldberg NH, Schneeweiss S, Kowal MK, et al. Availability of comparative efficacy data at the time of drug approval in the United States. JAMA 2011;305:1786-9.
    • (2011) JAMA , vol.305 , pp. 1786-1789
    • Goldberg, N.H.1    Schneeweiss, S.2    Kowal, M.K.3
  • 2
    • 84892726671 scopus 로고    scopus 로고
    • Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012
    • Downing NS, Aminawung JA, Shah ND, et al. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA 2014;311:368-77.
    • (2014) JAMA , vol.311 , pp. 368-377
    • Downing, N.S.1    Aminawung, J.A.2    Shah, N.D.3
  • 3
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    • Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011;305:2320-6.
    • (2011) JAMA , vol.305 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 4
    • 84878802996 scopus 로고    scopus 로고
    • Characteristics of oncology clinical trials: Insights from a systematic analysis of ClinicalTrials.gov
    • Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med 2013;173:972-9.
    • (2013) JAMA Intern Med , vol.173 , pp. 972-979
    • Hirsch, B.R.1    Califf, R.M.2    Cheng, S.K.3
  • 5
    • 0012164128 scopus 로고    scopus 로고
    • NDA 21-335/S-001
    • US Food and Drug Administration, Center for Drug Evaluation and Research. NDA 21-335/S-001. 2002. www.accessdata.fda.gov/drugsatfda-docs/appletter/2002/21335s001ltr.pdf.
    • (2002) Center for Drug Evaluation and Research
  • 6
    • 0012164128 scopus 로고    scopus 로고
    • NDA 021588/S-037
    • US Food and Drug Administration, Center for Drug Evaluation and Research. NDA 021588/S-037. 2013. www.accessdata.fda.gov/drugsatfda-docs/appletter/2013/021588Orig1s037ltr.pdf.
    • (2013) Center for Drug Evaluation and Research
  • 9
    • 84887698540 scopus 로고    scopus 로고
    • The impact of incremental innovation in biopharmaceuticals: Drug utilization in original and supplemental indications
    • Berndt ER, Cockburn IM, Grépin KA. The impact of incremental innovation in biopharmaceuticals: drug utilization in original and supplemental indications. Pharmacoeconomics 2006;24(suppl 2):69-86.
    • (2006) Pharmacoeconomics , vol.24 , pp. 69-86
    • Berndt, E.R.1    Cockburn, I.M.2    Grépin, K.A.3
  • 10
    • 84879459828 scopus 로고    scopus 로고
    • Innovating by developing new uses of already-approved drugs: Trends in the marketing approval of supplemental indications
    • DiMasi JA. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications. Clin Ther 2013;35:808-18.
    • (2013) Clin Ther , vol.35 , pp. 808-818
    • DiMasi, J.A.1
  • 11
    • 0030012853 scopus 로고    scopus 로고
    • An analysis of regulatory review times of supplemental indications for already-approved drugs: 1989-1994
    • DiMasi JA, Brown JS, Lasagna L. An analysis of regulatory review times of supplemental indications for already-approved drugs: 1989-1994. Drug Inf J 1996;30:315-37.
    • (1996) Drug Inf J , vol.30 , pp. 315-337
    • DiMasi, J.A.1    Brown, J.S.2    Lasagna, L.3
  • 12
    • 0025857491 scopus 로고
    • New indications for already-approved drugs: An analysis of regulatory review times
    • DiMasi JA, Kaitin KI, Fernandez-Carol C, et al. New indications for already-approved drugs: an analysis of regulatory review times. J Clin Pharmacol 1991;31:205-15.
    • (1991) J Clin Pharmacol , vol.31 , pp. 205-215
    • DiMasi, J.A.1    Kaitin, K.I.2    Fernandez-Carol, C.3
  • 14
    • 13144272331 scopus 로고    scopus 로고
    • US Food and Drug Administration. Orphan Drug Act. http://www.fda.gov/regulatoryinformation/legislation/significantamendmentstothefdcact/orphandrugact/default.htm.
    • Orphan Drug Act
  • 15
    • 0012164128 scopus 로고    scopus 로고
    • sBLA 103000/5251
    • US Food and Drug Administration, Center for Drug Evaluation and Research. sBLA 103000/5251. www.accessdata.fda.gov/drugsatfda-docs/appletter/2013/103000Orig1s5251ltr.pdf.
    • Center for Drug Evaluation and Research
  • 16
    • 0141566431 scopus 로고    scopus 로고
    • Prevalence and burden of overactive bladder in the United States
    • Stewart WF, Van Rooyen JB, Cundif GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327-36.
    • (2003) World J Urol , vol.20 , pp. 327-336
    • Stewart, W.F.1    Van Rooyen, J.B.2    Cundif, G.W.3
  • 17
    • 84859853303 scopus 로고    scopus 로고
    • Rheumatoid arthritis disease activity measures: American college of rheumatology recommendations for use in clinical practice
    • Anderson J, Caplan L, Yazdany J, et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken) 2012;64:640-7.
    • (2012) Arthritis Care Res (Hoboken) , vol.64 , pp. 640-647
    • Anderson, J.1    Caplan, L.2    Yazdany, J.3
  • 19
    • 33846878293 scopus 로고    scopus 로고
    • Economic return of clinical trials performed under the pediatric exclusivity program
    • Li JS, Eisenstein EL, Grabowski HG, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 2007;297:480-8.
    • (2007) JAMA , vol.297 , pp. 480-488
    • Li, J.S.1    Eisenstein, E.L.2    Grabowski, H.G.3
  • 20
    • 0141857724 scopus 로고    scopus 로고
    • Developmental pharmacology-drug disposition, action, and therapy in infants and children
    • Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349:1157-67.
    • (2003) N Engl J Med , vol.349 , pp. 1157-1167
    • Kearns, G.L.1    Abdel-Rahman, S.M.2    Alander, S.W.3
  • 21
    • 84927927121 scopus 로고    scopus 로고
    • Dosing in neonates: Special considerations in physiology and trial design
    • Ku LC, Smith PB. Dosing in neonates: special considerations in physiology and trial design. Pediatr Res 2015;77:2-9.
    • (2015) Pediatr Res , vol.77 , pp. 2-9
    • Ku, L.C.1    Smith, P.B.2
  • 22
    • 0030931530 scopus 로고    scopus 로고
    • Aging and pharmacology
    • Vestal RE. Aging and pharmacology. Cancer 2000;80:1302-10.
    • (2000) Cancer , vol.80 , pp. 1302-1310
    • Vestal, R.E.1
  • 23
    • 84947214775 scopus 로고    scopus 로고
    • 21st Century Cures Act
    • US House of Representatives. 21st Century Cures Act. 2015 http://docs.house.gov/meetings/IF/IF00/20150519/103516/BILLS-1146ih.pdf.
    • (2015) US House of Representatives
  • 24
    • 78149349684 scopus 로고    scopus 로고
    • US Food and Drug Administration. FDA's sentinel initiative. www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm.
    • FDA's Sentinel Initiative
  • 26
    • 84933673788 scopus 로고    scopus 로고
    • Electronic health data for postmarket surveillance: A vision not realized
    • Moore TJ, Furberg CD. Electronic health data for postmarket surveillance: a vision not realized. Drug Saf 2015;38:601-10.
    • (2015) Drug Saf , vol.38 , pp. 601-610
    • Moore, T.J.1    Furberg, C.D.2
  • 27
    • 84922732597 scopus 로고    scopus 로고
    • Assessing the safety and effectiveness of devices after US food and drug administration approval: Fda-mandated postapproval studies
    • Reynolds IS, Rising JP, Coukell AJ, et al. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med 2014;174:1773-9.
    • (2014) JAMA Intern Med , vol.174 , pp. 1773-1779
    • Reynolds, I.S.1    Rising, J.P.2    Coukell, A.J.3
  • 28
    • 84880160766 scopus 로고    scopus 로고
    • The food and drug administration amendments act and postmarketing commitments
    • Fain K, Daubresse M, Alexander GC. The Food and Drug Administration Amendments Act and postmarketing commitments. JAMA 2013;310:202-4.
    • (2013) JAMA , vol.310 , pp. 202-204
    • Fain, K.1    Daubresse, M.2    Alexander, G.C.3
  • 29
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    • Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011;305:2320-6.
    • (2011) JAMA , vol.305 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 30
    • 84896973049 scopus 로고    scopus 로고
    • New FDA breakthrough-drug category-implications for patients
    • Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category-implications for patients. N Engl J Med 2014;370:1252-8.
    • (2014) N Engl J Med , vol.370 , pp. 1252-1258
    • Darrow, J.J.1    Avorn, J.2    Kesselheim, A.S.3
  • 31
    • 84947249435 scopus 로고    scopus 로고
    • GlaxoSmithKline. Promacta prescribing information. 2012. www.accessdata.fda.gov/drugsatfda-docs/label/2012/022291s008lbl.pdf.
    • (2012) Promacta Prescribing Information


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.