Meeting on the FDA draft guidance on patient-reported outcomes

被引：5
|
作者：
Dueck, Amylou C. [1 ]
Sloan, Jeff A. [1 ]
机构：
[1] Mayo Clin, Dept Hlth Sci Res, Rochester, MN 55905 USA
来源：
VALUE IN HEALTH | 2007年 / 10卷
关键词：
D O I：
10.1111/j.1524-4733.2007.00268.x
中图分类号：
F [经济];
学科分类号：
02 ;
摘要：
引用
收藏
页码：S64 / S65
页数：2
相关论文
共 50 条
  • [21] Patient-reported outcomes in breast cancer FDA drug labels and review documents
    Hong, Kyungwan
    Majercak, Kayleigh R.
    Villalonga-Olives, Ester
    Perfetto, Eleanor M.
    JOURNAL OF PATIENT-REPORTED OUTCOMES, 2021, 5 (01)
  • [22] Patient-reported outcomes to support medical product labeling claims: FDA perspective
    Patrick, Donald L.
    Burke, Laurie B.
    Powers, John H.
    Scott, Jane A.
    Rock, Edwin P.
    Dawisha, Sahar
    O'Neill, Robert
    Kennedy, Dianne L.
    VALUE IN HEALTH, 2007, 10 : S125 - S137
  • [23] IDENTIFYING TRENDS AND IMPACTS OF THE FDA GUIDANCE FOR INDUSTRY ON PATIENT-REPORTED OUTCOMES (PROS) ON APPROVED PRODUCT LABELS, 2006-2013
    Palsgrove, A. C.
    Trivedi, B.
    Vanya, M.
    Cole, J. C.
    VALUE IN HEALTH, 2014, 17 (03) : A165 - A165
  • [24] Beyond the FDA PRO Guidance: Steps toward Integrating Meaningful Patient-Reported Outcomes into Regulatory Trials and US Drug Labels
    Basch, Ethan
    VALUE IN HEALTH, 2012, 15 (03) : 401 - 403
  • [25] Telemedizinische Erfassung von „patient-reported outcomes“Remote monitoring of patient-reported outcomes
    V. Siefert
    G. Welzel
    M. Blessing
    L. Jahnke
    J. Hesser
    F. Wenz
    F. A. Giordano
    Forum, 2018, 33 (2) : 94 - 100
  • [26] Responder Definition of a Patient-Reported Outcome Instrument for Laryngopharyngeal Reflux Based on the US FDA Guidance
    Lien, Han-Chung
    Wang, Chen-Chi
    Lee, Shou-Wu
    Hsu, Jeng-Yuan
    Yeh, Hong-Zen
    Ko, Chung-Wang
    Chang, Chi-Sen
    Liang, Wen-Miin
    VALUE IN HEALTH, 2015, 18 (04) : 396 - 403
  • [27] Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
    不详
    HEALTH AND QUALITY OF LIFE OUTCOMES, 2006, 4 (1)
  • [28] Patient-reported outcomes and patient voices
    Asci, Gulay
    Ok, Ercan
    SEMINARS IN DIALYSIS, 2022, 35 (05) : 457 - 458
  • [29] Patient copayments and patient-reported outcomes
    Mullins, CD
    CLINICAL THERAPEUTICS, 2002, 24 (04) : 674 - 674
  • [30] Patient-Reported Outcomes (Pros) and Patient-Reported Outcome Measures (Proms)
    Weldring, Theresa
    Smith, Sheree M. S.
    HEALTH SERVICES INSIGHTS, 2013, 6 : 61 - 68
12345