Expedited approval programs at the Food and Drug Administration

被引：1
|
作者：
Begg, Colin B. [1 ]
Ellenberg, Susan S. [2 ]
机构：
[1] Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, 2nd Floor,485 Lexington Ave, New York, NY 10017 USA
[2] Univ Penn, CCEB, Perelman Sch Med, Philadelphia, PA 19104 USA
来源：
CLINICAL TRIALS | 2018年 / 15卷 / 03期
关键词：
D O I：
10.1177/1740774518770653
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
引用
收藏
页码：217 / 218
页数：2
相关论文
共 50 条
  • [21] US Food and Drug Administration approval of esketamine and brexanolone
    Cristea, Ioana A.
    Naudet, Florian
    LANCET PSYCHIATRY, 2019, 6 (12): : 975 - 977
  • [22] Zohydro™ Approval by Food and Drug Administration: Controversial or Frightening?
    Manchikanti, Laxmaiah
    Atluri, Sairam
    Candido, Kenneth D.
    Boswell, Mark V.
    Simopoulos, Thomas T.
    Grider, Jay S.
    Falco, Frank J. E.
    Hirsch, Joshua A.
    PAIN PHYSICIAN, 2014, 17 (04) : E437 - E450
  • [23] Concern about the Food and Drug Administration's drug approval process
    不详
    AMERICAN JOURNAL OF PUBLIC HEALTH, 2000, 90 (03) : 466 - 467
  • [24] The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine
    Kantor, Ariel
    Haga, Susanne B.
    JOURNAL OF PERSONALIZED MEDICINE, 2021, 11 (01): : 1 - 10
  • [25] Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021
    Monge, Andrea N.
    Sigelman, Daniel W.
    Temple, Robert J.
    Chahal, Harinder Singh
    JAMA NETWORK OPEN, 2022, 5 (11) : e2239336
  • [26] FOOD AND DRUG ADMINISTRATION INDUSTRY INFORMATION PROGRAMS
    OKEEFE, HF
    FOOD DRUG COSMETIC LAW JOURNAL, 1966, 21 (01): : 52 - 56
  • [27] Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
    Kesselheim, Aaron S.
    Wang, Bo
    Franklin, Jessica M.
    Darrow, Jonathan J.
    BMJ-BRITISH MEDICAL JOURNAL, 2015, 351
  • [28] Reforming Reimbursement for the US Food and Drug Administration's Accelerated Approval Program to Support State Medicaid Programs
    Sachs, Rachel E.
    Donohue, Julie M.
    Dusetzina, Stacie B.
    JAMA HEALTH FORUM, 2022, 3 (11): : E224115
  • [29] Food and Drug Administration approval process for ophthalmic drugs in the US
    Lloyd, Rhea
    Harris, Jennifer
    Wadhwa, Sonal
    Chambers, Wiley
    CURRENT OPINION IN OPHTHALMOLOGY, 2008, 19 (03) : 190 - 194
  • [30] Transparency and Dermatologic Device Approval by the US Food and Drug Administration
    Ezaldein, Harib H.
    Scott, Jeffrey F.
    Yin, Emily S.
    Ventura, Alessandra
    DeRuyter, Nicholaas P.
    Leffell, David J.
    JAMA DERMATOLOGY, 2018, 154 (03) : 273 - 280
12345