FDA Revokes Approval for Preterm Birth Drug Makena

被引：2
|
作者：
Harris, Emily
机构：
来源：
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2023年 / 329卷 / 17期
关键词：
D O I：
10.1001/jama.2023.6257
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
[No abstract available]
引用
收藏
页码：1444 / 1444
页数：1
相关论文
共 50 条
  • [1] Withdrawing Approval of Makena - A Proposal from the FDA Center for Drug Evaluation and Research
    Chang, Christina Y.
    Nguyen, Christine P.
    Wesley, Barbara
    Guo, Jia
    Johnson, Laura Lee
    Joffe, Hylton V.
    NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (24):
  • [2] Withdrawing Approval of Makena-A Proposal From the FDA Center for Drug Evaluation and Research COMMENT
    不详
    OBSTETRICAL & GYNECOLOGICAL SURVEY, 2021, 76 (05) : 253 - 255
  • [3] The FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process
    Aaron, Daniel G.
    Cohen, I. Glenn
    Adashi, Eli Y.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 328 (24): : 2394 - 2395
  • [4] 17 α-Hydroxyprogesterone Caproate (Makena™) In the Prevention of Preterm Birth
    Deeks, Emma D.
    PEDIATRIC DRUGS, 2011, 13 (05) : 337 - 345
  • [5] 17 α-Hydroxyprogesterone Caproate (Makena™)In the Prevention of Preterm Birth
    Emma D. Deeks
    Pediatric Drugs, 2011, 13 : 337 - 345
  • [6] Preterm Birth and 17OHP-Why the FDA Should Not Withdraw Approval
    Greene, Michael F.
    Klebanoff, Mark A.
    Harrington, David
    NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (24):
  • [7] FDA and drug approval
    Faich, GA
    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 1995, 6 (06) : S24 - S24
  • [8] FDA panel says preterm birth drug should be withdrawn
    Jaffe, Susan
    LANCET, 2022, 400 (10362): : 1501 - 1501
  • [9] FDA AND DRUG APPROVAL PROCESS
    KENNEDY, D
    CONNECTICUT MEDICINE, 1978, 42 (10) : 651 - 656
  • [10] A lupus drug and FDA approval
    Merrill, JT
    Raymond, S
    SCIENCE, 2005, 308 (5721) : 497 - 497
12345