Hysteroscopic Sterilization With Essure: Summary of the US Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance

被引:1
|
作者
Steward, Rachel [1 ]
机构
[1] FPA Womens Hlth, Long Beach, CA 90806 USA
来源
OBSTETRICS AND GYNECOLOGY | 2017年 / 129卷 / 04期
关键词
D O I
10.1097/AOG.0000000000001961
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
引用
收藏
页码:752 / 753
页数:3
相关论文
共 50 条
  • [31] Prospective Surveillance Pilot of Rivaroxaban Safety Within the US Food and Drug Administration Sentinel System
    Chrischilles, Elizabeth A.
    Gagne, Joshua
    Fireman, Bruce
    Nelson, Jennifer C.
    Toh, Sengwee
    Shoaibi, Azadeh
    Reichman, Marsha E.
    Wang, Shirley V.
    Nguyen, Michael D.
    Zhang, Rongmei
    Izem, Rima
    Goulding, Margie R.
    Southworth, Mary Ross
    Graham, David J.
    Fuller, Candace C.
    Katcoff, Hannah
    Woodworth, Tiffany S.
    Rogers, Catherine
    Saliga, Ryan M.
    Lin, Nancy D.
    McMahill-Walraven, Cheryl N.
    Nair, Vinit P.
    Haynes, Kevin
    Carnahan, Ryan M.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 : 450 - 450
  • [32] US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
    Eadie, Ashley
    MacGregor, Andrea
    Wallach, Joshua
    Ross, Joseph
    Herder, Matthew
    BMJ EVIDENCE-BASED MEDICINE, 2023, 28 (03) : 151 - 156
  • [33] POLICY DEBATE: The US food and drug administration and new drug approvals: A safety vs. innovation paradox?
    Hemphill, Thomas A.
    INNOVATION-MANAGEMENT POLICY & PRACTICE, 2013, 15 (03): : 364 - 367
  • [34] Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials
    Shepshelovich, Daniel
    Tibau, Ariadna
    Goldvaser, Hadar
    Molto, Consolacion
    Ocana, Alberto
    Seruga, Bostjan
    Amir, Eitan
    JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (18) : 1798 - +
  • [35] An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the US Food and Drug Administration, 2012-2022
    Collins, Grace
    McKelvey, Brittany
    Andrews, Hillary S.
    Allen, Jeff D.
    Stewart, Mark D.
    CLINICAL CANCER RESEARCH, 2024, 30 (05) : 937 - 941
  • [36] US Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer
    Weinstock, Chana
    Khozin, Sean
    Suzman, Daniel
    Zhang, Lijun
    Tang, Shenghui
    Wahby, Sakar
    Goldberg, Kirsten B.
    Kim, Geoffrey
    Pazdur, Richard
    CLINICAL CANCER RESEARCH, 2017, 23 (16) : 4534 - 4539
  • [37] US Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia
    Ehrlich, Lori A.
    Kwitkowski, Virginia E.
    Reaman, Gregory
    Ko, Chia-Wen
    Nie, Lei
    Pazdur, Richard
    Farrell, Ann T.
    PEDIATRIC BLOOD & CANCER, 2017, 64 (12)
  • [38] Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017
    Zhu, Xingyue
    Liu, Bao
    BMJ OPEN, 2022, 12 (07):
  • [39] US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019
    Hidano, Danelle
    Dhruva, Sanket S.
    Redberg, Rita F.
    JAMA INTERNAL MEDICINE, 2022, 182 (05) : 556 - 558
  • [40] Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion
    Simmonds, Katherine E.
    Beal, Margaret W.
    Eagen-Torkko, Meghan K.
    JOURNAL OF MIDWIFERY & WOMENS HEALTH, 2017, 62 (03) : 348 - 352