Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration

被引:17
|
作者
Puthumana, Jeremy [1 ]
Egilman, Alexander C. [2 ]
Zhang, Audrey D. [3 ]
Schwartz, Jason L. [4 ]
Ross, Joseph S. [1 ,2 ,4 ]
机构
[1] Yale Sch Med, Dept Internal Med, New Haven, CT USA
[2] Yale New Haven Med Ctr, Ctr Outcomes Res & Evaluat, 20 York St, New Haven, CT 06504 USA
[3] Duke Univ, Sch Med, Dept Med, Durham, NC 27706 USA
[4] Yale Sch Publ Hlth, Dept Hlth Policy & Management, New Haven, CT USA
关键词
D O I
10.1001/jamainternmed.2020.7472
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
This cross-sectional study evaluates all of the novel vaccines approved by the US Food and Drug Administration over the last decade.
引用
收藏
页码:559 / 560
页数:2
相关论文
共 50 条
  • [1] Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
    Jiao, Kuo
    Gupta, Ravi
    Fox, Erin
    Kesselheim, Aaron
    Ross, Joseph S.
    [J]. JAMA NETWORK OPEN, 2019, 2 (10)
  • [2] Review of Evidence Supporting 2022 US Food and Drug Administration Drug Approvals
    Kaplan, Robert M.
    Koong, Amanda J.
    Irvin, Veronica
    [J]. JAMA NETWORK OPEN, 2023, 6 (08) : e2327650
  • [3] Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020
    Audrey D. Zhang
    Jeremy Puthumana
    Alexander C. Egilman
    Jason L. Schwartz
    Joseph S. Ross
    [J]. Journal of General Internal Medicine, 2022, 37 : 700 - 702
  • [4] Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020
    Zhang, Audrey D.
    Puthumana, Jeremy
    Egilman, Alexander C.
    Schwartz, Jason L.
    Ross, Joseph S.
    [J]. JOURNAL OF GENERAL INTERNAL MEDICINE, 2022, 37 (03) : 700 - 702
  • [5] Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020
    Mitra-Majumdar, Mayookha
    Gunter, Simon J.
    Kesselheim, Aaron S.
    Brown, Beatrice L.
    Joyce, Krysten W.
    Ross, Murray
    Pham, Catherine
    Avorn, Jerry
    Darrow, Jonathan J.
    [J]. JAMA NETWORK OPEN, 2022, 5 (05)
  • [6] Evidence Supporting US Food and Drug Administration Drug Safety Communications
    Ross, Joseph S.
    [J]. JAMA INTERNAL MEDICINE, 2019, 179 (11) : 1592 - 1592
  • [7] Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration
    Feldman, Daniel
    Avorn, Jerry
    Kesselheim, Aaron S.
    [J]. JAMA NETWORK OPEN, 2022, 5 (04) : E227958
  • [8] POLICY DEBATE: The US food and drug administration and new drug approvals: A safety vs. innovation paradox?
    Hemphill, Thomas A.
    [J]. INNOVATION-MANAGEMENT POLICY & PRACTICE, 2013, 15 (03): : 364 - 367
  • [9] The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020
    Gloy, Viktoria
    Schmitt, Andreas M.
    Dueblin, Pascal
    Hirt, Julian
    Axfors, Cathrin
    Kuk, Hanna
    Pereira, Tiago V.
    Locher, Clara
    Caquelin, Laura
    Walter-Claudi, Martin
    Lythgoe, Mark P.
    Herbrand, Amanda
    Kasenda, Benjamin
    Hemkens, Lars G.
    [J]. INTERNATIONAL JOURNAL OF CANCER, 2023, 152 (12) : 2474 - 2484
  • [10] Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration
    Hilal, Talal
    Gonzalez-Velez, Miguel
    Prasad, Vinay
    [J]. JAMA INTERNAL MEDICINE, 2020, 180 (08) : 1108 - 1115